Clincosm LogoSign in Get a demo

A Study of Tarceva (Erlotinib) in Combination With Gemcitabine in Unresectable and/or Metastatic Cancer of the Pancreas: Relationship Between Skin Toxicity and Survival

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT00461708
Collaborator
(none)
153
Enrollment
29
Locations
2
Arms
42.1
Duration (Months)
5.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This single arm study will evaluate the relationship between the skin toxicity of Tarceva in combination with gemcitabine, and survival, in patients with advanced and/or metastatic pancreatic cancer. All patients will receive gemcitabine 100mg/m2 i.v. weekly; Tarceva will be administered 100mg po per day. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
153 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open Label Study of Tarceva in Combination With Gemcitabine in Unresectable and/or Metastatic Cancer of the Pancreas : Relationship Between Skin Rash and Survival
Study Start Date :
May 1, 2007
Actual Primary Completion Date :
Nov 1, 2010
Actual Study Completion Date :
Nov 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: Rash, Grade <2

Participants with a rash graded less than (<) 2 according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version (v.) 3.0 received erlotinib, 100 milligrams (mg), orally (PO), once per day until disease progression, unacceptable toxicity or refusal of patient to continue with the treatment. Participants also received gemcitabine, 1000 mg per (/) square meter (m^2), intravenously (IV), over 30 minutes on Days 1, 8 and 15 in 4-week cycles until disease progression, unacceptable toxicity or refusal of patient to continue with the treatment.

Drug: Erlotinib
100 mg, PO, once per day
Other Names:
  • Tarceva

    • Drug: Gemcitabine
    1000 mg/m2, IV, on Days 1, 8 and 15 in 4-week cycles
    Experimental: Rash, Grade ≥2

    Participants with a rash graded greater than or equal to (≥) 2 according to the NCI-CTC v. 3.0 received erlotinib, 100 mg, PO, once per day until disease progression, unacceptable toxicity or refusal of patient to continue with the treatment. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 in 4-week cycles until disease progression, unacceptable toxicity or refusal of patient to continue with the treatment.

    Drug: Erlotinib
    100 mg, PO, once per day
    Other Names:
  • Tarceva

    • Drug: Gemcitabine
    1000 mg/m2, IV, on Days 1, 8 and 15 in 4-week cycles

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants Who Died During the Study [Enrollment through Cycle 24 (4-week cycles), up to 24 months.]

    2. Overall Survival (OS) During the Study [Enrollment through Cycle 24 (4-week cycles), up to 24 months.]

      OS was defined as the time, in months, from the date of enrollment to the date of death due to any cause. Participants whose last recorded status was not death were censored. OS was estimated using Kaplan-Meier methodology.

    Secondary Outcome Measures

    1. Number of Participants Who Died at 6 Months [Enrollment through Cycle 6 (4-week cycles), up to 6 months.]

    2. OS At 6 Months [Enrollment through Cycle 6 (4-week cycles), up to 6 months.]

      OS was defined as the time, in months, from the date of enrollment to the date of death due to any cause. Participants whose last recorded status was not death were censored. OS was estimated using Kaplan-Meier methodology.

    3. Number of Participants Who Died During the Study By Rash Grade [Enrollment through Cycle 24 (4-week cycles), up to 24 months.]

    4. OS By Rash Grade [Enrollment through Cycle 24 (4-week cycles), up to 24 months.]

      OS was defined as the time, in months, from the date of enrollment to the date of death due to any cause. Participants whose last recorded status was not death were censored. OS was estimated using Kaplan-Meier methodology.

    5. Number of Participants With Disease Progression or Death [Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months.]

      Progression-free survival (PFS) was defined as the time from the date of enrollment to the date of document disease progression or death due to any cause. As per Response Evaluation Criteria in Solid Tumors (RECIST) V 1.0, progressive disease (PD) was defined for target lesions (TLs) as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded since the start of treatment, and for non-target lesions (NTLs) as unequivocal progression of NTLs. Participants whose last recorded status was not PD or death were censored.

    6. PFS [Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months]

      The time, in months, from enrollment to PFS event. Participants whose last recorded status was not progression or death were censored. PFS was estimated using Kaplan-Meier methodology.

    7. Percentage of Participants With Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) According to RECIST [Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months.]

      As per RECIST V 1.0: for TLs, a CR was defined as the disappearance of all TLs; and a PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline (BL) SLD. For NTLs, a CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. Participants for whom no assessment of response was available and who had finalized the study due to disease progression or tumor-related death, disease progression was considered the BOR.

    8. Percentage of Participants With Disease Control According to RECIST [Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months.]

      Disease control was defined as BOR of CR, PR, or stable disease (SD). As per RECIST V 1.0: for TLs, a CR was defined as the disappearance of all TLs; and a PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD. For NTLs, a CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD was defined as the persistence of one or more NTLs and/or maintenance of tumor marker level above the normal limits. Participants for whom no assessment of response was available and who had finalized the study due to disease progression or tumor-related death, disease progression was considered the BOR.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • adult patients, >=18 years of age;

    • locally advanced and/or metastatic pancreatic cancer (stage III or IV);

    • Karnofsky performance Status of >=60%.

    Exclusion Criteria:

    • local(stage IA to IIB) pancreatic cancer;

    • <=6 months since last adjuvant chemotherapy;

    • previous systemic therapy for metastatic pancreatic cancer;

    • other primary tumor within last 5 years (except for adequately treated cancer in situ of cervix, or basal cell skin cancer);

    • clinically significant cardiovascular disease.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Alcoy Alicante Spain 03804
    2 Elche Alicante Spain 03203
    3 Manresa Barcelona Spain 08243
    4 Sabadell, Barcelona Barcelona Spain 08208
    5 Santander Cantabria Spain 39008
    6 Palma de Mallorca Islas Baleares Spain 07198
    7 La Coruna La Coruña Spain 15006
    8 Alcorcon Madrid Spain 28922
    9 Sagunto Valencia Spain 46520
    10 Barcelona Spain 08227
    11 Barcelona Spain 08906
    12 Barcelona Spain 08907
    13 Barcelona Spain 08916
    14 Cordoba Spain 14004
    15 Girona Spain 17007
    16 Granada Spain 18014
    17 Guadalajara Spain 19002
    18 Jaen Spain 23007
    19 Lerida Spain 25198
    20 Lugo Spain 27004
    21 Madrid Spain 28040
    22 Madrid Spain 28041
    23 Murcia Spain 30008
    24 Murcia Spain 30120
    25 Navarra Spain 31008
    26 Pontevedra Spain 36002
    27 Sevilla Spain 41013
    28 Valencia Spain 41014
    29 Zaragoza Spain 50009

    Sponsors and Collaborators

    • Hoffmann-La Roche

    Investigators

    • Study Director: Clinical Trials, Hoffmann-La Roche

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hoffmann-La Roche
    ClinicalTrials.gov Identifier:
    NCT00461708
    Other Study ID Numbers:
    • ML20296
    First Posted:
    Apr 18, 2007
    Last Update Posted:
    Oct 15, 2015
    Last Verified:
    Sep 1, 2015
    Additional relevant MeSH terms:
    Pancreatic Neoplasms
    Neoplasm Metastasis
    Gemcitabine
    Erlotinib Hydrochloride

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Erlotinib, Gemcitabine: Rash Grade Less Than (<) 2 Erlotinib, Gemcitabine: Rash Grade Greater Than/Equal to (≥) 2
    Arm/Group Description Participants with a rash Grade < 2 according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version (V) 3.0 received erlotinib, 100 milligrams (mg), orally (PO), once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 milligrams per square meter (mg/m^2), intravenously (IV), over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
    Period Title: Overall Study
    STARTED 115 38
    COMPLETED 0 0
    NOT COMPLETED 115 38

    Baseline Characteristics

    Arm/Group Title Erlotinib, Gemcitabine: Rash Grade < 2 Erlotinib, Gemcitabine: Rash Grade ≥ 2 Total
    Arm/Group Description Participants with a rash Grade < 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Total of all reporting groups
    Overall Participants 115 38 153
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    63.6
    (9.9)
    62.0
    (10.6)
    63.2
    (10.1)
    Sex: Female, Male (Count of Participants)
    Female
    61
    53%
    10
    26.3%
    71
    46.4%
    Male
    54
    47%
    28
    73.7%
    82
    53.6%

    Outcome Measures

    1. Primary Outcome
    Title Number of Participants Who Died During the Study
    Description
    Time Frame Enrollment through Cycle 24 (4-week cycles), up to 24 months.

    Outcome Measure Data

    Analysis Population Description
    ITT population
    Arm/Group Title Erlotinib, Gemcitabine: Rash Grade < 2 Erlotinib, Gemcitabine: Rash Grade ≥ 2
    Arm/Group Description Participants with a rash Grade < 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
    Measure Participants 115 38
    Number [participants]
    102
    88.7%
    27
    71.1%
    2. Primary Outcome
    Title Overall Survival (OS) During the Study
    Description OS was defined as the time, in months, from the date of enrollment to the date of death due to any cause. Participants whose last recorded status was not death were censored. OS was estimated using Kaplan-Meier methodology.
    Time Frame Enrollment through Cycle 24 (4-week cycles), up to 24 months.

    Outcome Measure Data

    Analysis Population Description
    ITT population; only participants who died were included in the analysis.
    Arm/Group Title Erlotinib, Gemcitabine: Rash Grade < 2 Erlotinib, Gemcitabine: Rash Grade ≥ 2
    Arm/Group Description Participants with a rash Grade < 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
    Measure Participants 102 27
    Median (95% Confidence Interval) [months]
    4.468
    10.546
    3. Secondary Outcome
    Title Number of Participants Who Died at 6 Months
    Description
    Time Frame Enrollment through Cycle 6 (4-week cycles), up to 6 months.

    Outcome Measure Data

    Analysis Population Description
    ITT population
    Arm/Group Title Erlotinib, Gemcitabine: Rash Grade < 2 Erlotinib, Gemcitabine: Rash Grade ≥ 2
    Arm/Group Description Participants with a rash Grade < 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
    Measure Participants 115 38
    Number [participants]
    69
    60%
    8
    21.1%
    4. Secondary Outcome
    Title OS At 6 Months
    Description OS was defined as the time, in months, from the date of enrollment to the date of death due to any cause. Participants whose last recorded status was not death were censored. OS was estimated using Kaplan-Meier methodology.
    Time Frame Enrollment through Cycle 6 (4-week cycles), up to 6 months.

    Outcome Measure Data

    Analysis Population Description
    ITT population; only participants who died were included in the analysis.
    Arm/Group Title Erlotinib, Gemcitabine: Rash Grade < 2 Erlotinib, Gemcitabine: Rash Grade ≥ 2
    Arm/Group Description Participants with a rash Grade < 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
    Measure Participants 69 8
    Median (95% Confidence Interval) [months]
    4.468
    NA
    5. Secondary Outcome
    Title Number of Participants Who Died During the Study By Rash Grade
    Description
    Time Frame Enrollment through Cycle 24 (4-week cycles), up to 24 months.

    Outcome Measure Data

    Analysis Population Description
    ITT population
    Arm/Group Title Erlotinib, Gemcitabine: Rash Grade 0 Erlotinib, Gemcitabine: Rash Grade 1 Erlotinib, Gemcitabine: Rash Grade ≥ 2
    Arm/Group Description Participants with a rash Grade 0 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants with a rash Grade 1 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
    Measure Participants 71 44 38
    Number [participants]
    65
    56.5%
    37
    97.4%
    27
    17.6%
    6. Secondary Outcome
    Title OS By Rash Grade
    Description OS was defined as the time, in months, from the date of enrollment to the date of death due to any cause. Participants whose last recorded status was not death were censored. OS was estimated using Kaplan-Meier methodology.
    Time Frame Enrollment through Cycle 24 (4-week cycles), up to 24 months.

    Outcome Measure Data

    Analysis Population Description
    ITT population; only participants who died were included in the analysis.
    Arm/Group Title Erlotinib, Gemcitabine: Rash Grade 0 Erlotinib, Gemcitabine: Rash Grade 1 Erlotinib, Gemcitabine: Rash Grade ≥ 2
    Arm/Group Description Participants with a rash Grade 0 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants with a rash Grade 1 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
    Measure Participants 65 37 27
    Median (95% Confidence Interval) [months]
    3.318
    6.571
    10.546
    7. Secondary Outcome
    Title Number of Participants With Disease Progression or Death
    Description Progression-free survival (PFS) was defined as the time from the date of enrollment to the date of document disease progression or death due to any cause. As per Response Evaluation Criteria in Solid Tumors (RECIST) V 1.0, progressive disease (PD) was defined for target lesions (TLs) as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded since the start of treatment, and for non-target lesions (NTLs) as unequivocal progression of NTLs. Participants whose last recorded status was not PD or death were censored.
    Time Frame Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months.

    Outcome Measure Data

    Analysis Population Description
    ITT population
    Arm/Group Title Erlotinib, Gemcitabine: Rash Grade < 2 Erlotinib, Gemcitabine: Rash Grade ≥ 2
    Arm/Group Description Participants with a rash Grade < 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
    Measure Participants 115 38
    Number [participants]
    110
    95.7%
    33
    86.8%
    8. Secondary Outcome
    Title PFS
    Description The time, in months, from enrollment to PFS event. Participants whose last recorded status was not progression or death were censored. PFS was estimated using Kaplan-Meier methodology.
    Time Frame Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months

    Outcome Measure Data

    Analysis Population Description
    ITT population; only participants with an event (death or disease progression) were included in the analysis.
    Arm/Group Title Erlotinib, Gemcitabine: Rash Grade < 2 Erlotinib, Gemcitabine: Rash Grade ≥ 2
    Arm/Group Description Participants with a rash Grade < 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
    Measure Participants 110 33
    Median (95% Confidence Interval) [months]
    2.497
    6.439
    9. Secondary Outcome
    Title Percentage of Participants With Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) According to RECIST
    Description As per RECIST V 1.0: for TLs, a CR was defined as the disappearance of all TLs; and a PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline (BL) SLD. For NTLs, a CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. Participants for whom no assessment of response was available and who had finalized the study due to disease progression or tumor-related death, disease progression was considered the BOR.
    Time Frame Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months.

    Outcome Measure Data

    Analysis Population Description
    ITT population
    Arm/Group Title Erlotinib, Gemcitabine: Rash Grade < 2 Erlotinib, Gemcitabine: Rash Grade ≥ 2
    Arm/Group Description Participants with a rash Grade < 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
    Measure Participants 115 38
    Number [percentage of participants]
    7.0
    6.1%
    21.1
    55.5%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Erlotinib, Gemcitabine: Rash Grade < 2, Erlotinib, Gemcitabine: Rash Grade ≥ 2
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.05
    Comments
    Method Chi-squared
    Comments
    10. Secondary Outcome
    Title Percentage of Participants With Disease Control According to RECIST
    Description Disease control was defined as BOR of CR, PR, or stable disease (SD). As per RECIST V 1.0: for TLs, a CR was defined as the disappearance of all TLs; and a PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD. For NTLs, a CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD was defined as the persistence of one or more NTLs and/or maintenance of tumor marker level above the normal limits. Participants for whom no assessment of response was available and who had finalized the study due to disease progression or tumor-related death, disease progression was considered the BOR.
    Time Frame Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months.

    Outcome Measure Data

    Analysis Population Description
    ITT population
    Arm/Group Title Erlotinib, Gemcitabine: Rash Grade < 2 Erlotinib, Gemcitabine: Rash Grade ≥ 2
    Arm/Group Description Participants with a rash Grade < 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
    Measure Participants 115 38
    Number [percentage of participants]
    42.6
    37%
    84.2
    221.6%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Erlotinib, Gemcitabine: Rash Grade < 2, Erlotinib, Gemcitabine: Rash Grade ≥ 2
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.05
    Comments
    Method Chi-squared
    Comments

    Adverse Events

    Time Frame Adverse events (AEs) were recorded at every study visit for up to a maximum of 24 treatment cycles.
    Adverse Event Reporting Description All participants who received at least 1 dose of study treatment were included in the safety analysis.
    Arm/Group Title Erlotinib, Gemcitabine: Rash Grade < 2 Erlotinib, Gemcitabine: Rash Grade ≥ 2
    Arm/Group Description Participants with a rash Grade < 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
    All Cause Mortality
    Erlotinib, Gemcitabine: Rash Grade < 2 Erlotinib, Gemcitabine: Rash Grade ≥ 2
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Erlotinib, Gemcitabine: Rash Grade < 2 Erlotinib, Gemcitabine: Rash Grade ≥ 2
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 58/115 (50.4%) 14/38 (36.8%)
    Blood and lymphatic system disorders
    Anaemia 1/115 (0.9%) 0/38 (0%)
    Myelosuppression 1/115 (0.9%) 0/38 (0%)
    Thrombocytopenia 1/115 (0.9%) 0/38 (0%)
    Cardiac disorders
    Pericardial effusion 1/115 (0.9%) 0/38 (0%)
    Cardiac failure congestive 1/115 (0.9%) 0/38 (0%)
    Left ventricular dysfunction 0/115 (0%) 1/38 (2.6%)
    Valvular heart disease 0/115 (0%) 1/38 (2.6%)
    Gastrointestinal disorders
    Haemorrhage, GI 3/115 (2.6%) 1/38 (2.6%)
    Gastrointestinal toxicity 1/115 (0.9%) 0/38 (0%)
    Vomiting 2/115 (1.7%) 0/38 (0%)
    Haemorrhage, rectal 1/115 (0.9%) 0/38 (0%)
    Diarrhea 1/115 (0.9%) 0/38 (0%)
    Gastrointestinal syndrome 1/115 (0.9%) 0/38 (0%)
    Obstruction, GI 11/115 (9.6%) 2/38 (5.3%)
    Perforation, GI 1/115 (0.9%) 0/38 (0%)
    Visceral arterial ischemia 1/115 (0.9%) 0/38 (0%)
    Pancreatitis 1/115 (0.9%) 1/38 (2.6%)
    Abdomen nos 5/115 (4.3%) 0/38 (0%)
    General disorders
    Sudden death 1/115 (0.9%) 0/38 (0%)
    Fatigue 4/115 (3.5%) 1/38 (2.6%)
    Fever 4/115 (3.5%) 2/38 (5.3%)
    Pain 0/115 (0%) 1/38 (2.6%)
    Hepatobiliary disorders
    Bilirubin (Hyperbilirubinemia) 1/115 (0.9%) 0/38 (0%)
    Liver dysfunction 1/115 (0.9%) 0/38 (0%)
    Liver dysfunction/failure 1/115 (0.9%) 0/38 (0%)
    Infections and infestations
    Anal/perianal 1/115 (0.9%) 0/38 (0%)
    Blood 4/115 (3.5%) 2/38 (5.3%)
    Cellulitis 1/115 (0.9%) 0/38 (0%)
    Lung (pneumonia) 3/115 (2.6%) 3/38 (7.9%)
    Peritoneal cavity 1/115 (0.9%) 1/38 (2.6%)
    Upper airway nos 1/115 (0.9%) 0/38 (0%)
    Urinary tract nos 1/115 (0.9%) 0/38 (0%)
    Investigations
    Weight loss 0/115 (0%) 1/38 (2.6%)
    Metabolism and nutrition disorders
    Calcium, serum-low (hypocalcemia) 1/115 (0.9%) 0/38 (0%)
    Glucose, serum-high (hyperglycemia) 1/115 (0.9%) 0/38 (0%)
    Diabetes 3/115 (2.6%) 0/38 (0%)
    Musculoskeletal and connective tissue disorders
    Back pain 1/115 (0.9%) 0/38 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Benign prostatic hyperplasia 1/115 (0.9%) 0/38 (0%)
    Tumor pain 1/115 (0.9%) 0/38 (0%)
    Nervous system disorders
    Haemorrhage, CNS 1/115 (0.9%) 0/38 (0%)
    CNS Cerebrovascular ischemia 1/115 (0.9%) 2/38 (5.3%)
    Speech impairment 0/115 (0%) 1/38 (2.6%)
    Psychiatric disorders
    Confusion 1/115 (0.9%) 0/38 (0%)
    Renal and urinary disorders
    Obstruction, GU 1/115 (0.9%) 0/38 (0%)
    Renal failure 1/115 (0.9%) 0/38 (0%)
    Respiratory, thoracic and mediastinal disorders
    Respiratory failure 1/115 (0.9%) 1/38 (2.6%)
    Dyspnea 3/115 (2.6%) 0/38 (0%)
    Surgical and medical procedures
    Liver 1/115 (0.9%) 0/38 (0%)
    Vascular disorders
    Hypertension 1/115 (0.9%) 0/38 (0%)
    Thrombosis/Embolism 3/115 (2.6%) 1/38 (2.6%)
    Thrombosis/Thrombus 3/115 (2.6%) 0/38 (0%)
    Visceral arterial ischemia 1/115 (0.9%) 0/38 (0%)
    Other (Not Including Serious) Adverse Events
    Erlotinib, Gemcitabine: Rash Grade < 2 Erlotinib, Gemcitabine: Rash Grade ≥ 2
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 115/115 (100%) 38/38 (100%)
    Blood and lymphatic system disorders
    Neutropenia 20/115 (17.4%) 16/38 (42.1%)
    Lymphopenia 2/115 (1.7%) 0/38 (0%)
    Monocytopenia 1/115 (0.9%) 0/38 (0%)
    Thrombocytosis 1/115 (0.9%) 0/38 (0%)
    Anaemia 32/115 (27.8%) 11/38 (28.9%)
    Granulocytopenia 1/115 (0.9%) 0/38 (0%)
    Hemoglobin 3/115 (2.6%) 1/38 (2.6%)
    Hemorrhage 1/115 (0.9%) 0/38 (0%)
    Leukocytes 0/115 (0%) 1/38 (2.6%)
    Leukocytosis 3/115 (2.6%) 0/38 (0%)
    Leukopenia 8/115 (7%) 3/38 (7.9%)
    Edema 11/115 (9.6%) 3/38 (7.9%)
    Edema: limb 22/115 (19.1%) 2/38 (5.3%)
    Lymphatics- other 1/115 (0.9%) 0/38 (0%)
    Thrombopenia 21/115 (18.3%) 10/38 (26.3%)
    Cardiac disorders
    Atrial fibrillation 1/115 (0.9%) 0/38 (0%)
    Left ventricular dysfunction 0/115 (0%) 2/38 (5.3%)
    Ear and labyrinth disorders
    Hearing loss 1/115 (0.9%) 0/38 (0%)
    Endocrine disorders
    Endocrine- other 1/115 (0.9%) 0/38 (0%)
    Eye disorders
    Cataract 0/115 (0%) 1/38 (2.6%)
    Eyelid dysfunction 1/115 (0.9%) 0/38 (0%)
    Ocular surface disease 1/115 (0.9%) 0/38 (0%)
    Vision - Blurred vision 1/115 (0.9%) 0/38 (0%)
    Ocular/visual- other 2/115 (1.7%) 0/38 (0%)
    Gastrointestinal disorders
    Nausea 43/115 (37.4%) 12/38 (31.6%)
    Constipation 38/115 (33%) 12/38 (31.6%)
    Vomiting 34/115 (29.6%) 8/38 (21.1%)
    Ascites 7/115 (6.1%) 2/38 (5.3%)
    Flatulence 3/115 (2.6%) 2/38 (5.3%)
    Oral cavity 0/115 (0%) 1/38 (2.6%)
    Dysphagia 2/115 (1.7%) 0/38 (0%)
    Gastritis 2/115 (1.7%) 0/38 (0%)
    Diarrhea 55/115 (47.8%) 15/38 (39.5%)
    Gastrointestinal - other 21/115 (18.3%) 5/38 (13.2%)
    Gastrointestinal toxicity 1/115 (0.9%) 0/38 (0%)
    Heartburn/dyspepsia 13/115 (11.3%) 3/38 (7.9%)
    Hemorrhoids 3/115 (2.6%) 1/38 (2.6%)
    Mucositis/stomatitis 19/115 (16.5%) 9/38 (23.7%)
    Obstruction, GI 2/115 (1.7%) 1/38 (2.6%)
    Perforation, GI 1/115 (0.9%) 0/38 (0%)
    Periodontal disease 1/115 (0.9%) 0/38 (0%)
    Xerostomia 6/115 (5.2%) 2/38 (5.3%)
    Anal haemorrhage 1/115 (0.9%) 0/38 (0%)
    Hemorrhage rectal 1/115 (0.9%) 0/38 (0%)
    Pancreas, exocrine 3/115 (2.6%) 0/38 (0%)
    Distension/bloating 3/115 (2.6%) 3/38 (7.9%)
    General disorders
    Fever 18/115 (15.7%) 11/38 (28.9%)
    Fatigue 89/115 (77.4%) 31/38 (81.6%)
    Chills 1/115 (0.9%) 0/38 (0%)
    Constitutional symptoms- other 11/115 (9.6%) 6/38 (15.8%)
    Other 1/115 (0.9%) 0/38 (0%)
    Chest/thorax nos 2/115 (1.7%) 0/38 (0%)
    Pain 18/115 (15.7%) 8/38 (21.1%)
    Peritoneum 1/115 (0.9%) 0/38 (0%)
    Skin 0/115 (0%) 1/38 (2.6%)
    Nasal/ paranasal 1/115 (0.9%) 1/38 (2.6%)
    Hepatobiliary disorders
    Liver dysfunction 8/115 (7%) 3/38 (7.9%)
    Bilirubin 4/115 (3.5%) 4/38 (10.5%)
    Immune system disorders
    Allergic reaction 1/115 (0.9%) 0/38 (0%)
    Allergy /immunology- other 2/115 (1.7%) 0/38 (0%)
    Infections and infestations
    Esophagitis 1/115 (0.9%) 1/38 (2.6%)
    Myelitis 0/115 (0%) 1/38 (2.6%)
    Rhinitis 1/115 (0.9%) 1/38 (2.6%)
    Proctitis 1/115 (0.9%) 0/38 (0%)
    Abdomen nos 0/115 (0%) 1/38 (2.6%)
    Anal/perianal 1/115 (0.9%) 0/38 (0%)
    Blood 1/115 (0.9%) 1/38 (2.6%)
    Conjunctiva 5/115 (4.3%) 0/38 (0%)
    Infection 1/115 (0.9%) 0/38 (0%)
    Lung (Pneumonia) 1/115 (0.9%) 1/38 (2.6%)
    Middle ear 0/115 (0%) 1/38 (2.6%)
    Oral cavity-gums 2/115 (1.7%) 0/38 (0%)
    Skin 3/115 (2.6%) 0/38 (0%)
    Soft tissue nos 1/115 (0.9%) 0/38 (0%)
    Upper airway nos 6/115 (5.2%) 3/38 (7.9%)
    Urinary tract nos 3/115 (2.6%) 1/38 (2.6%)
    Cystitis 6/115 (5.2%) 2/38 (5.3%)
    Injury, poisoning and procedural complications
    Fracture 1/115 (0.9%) 0/38 (0%)
    Investigations
    Weight loss 27/115 (23.5%) 5/38 (13.2%)
    Alkaline phosphatase 3/115 (2.6%) 0/38 (0%)
    ALT, SGPT 1/115 (0.9%) 1/38 (2.6%)
    ALT, SGPT 4/115 (3.5%) 2/38 (5.3%)
    GGT (Gamma-glutamyl) 5/115 (4.3%) 1/38 (2.6%)
    Metabolism and nutrition disorders
    Anorexia 62/115 (53.9%) 11/38 (28.9%)
    Obesity 2/115 (1.7%) 0/38 (0%)
    Sweating 1/115 (0.9%) 0/38 (0%)
    Diabetes 2/115 (1.7%) 1/38 (2.6%)
    Albumin, serum-low 1/115 (0.9%) 0/38 (0%)
    Calcium, serum high 4/115 (3.5%) 1/38 (2.6%)
    Glucose, serum high 6/115 (5.2%) 1/38 (2.6%)
    Glucose, serum low 5/115 (4.3%) 1/38 (2.6%)
    Hypercreatinaemia 0/115 (0%) 1/38 (2.6%)
    Magnesium, serum low 3/115 (2.6%) 1/38 (2.6%)
    Metabolic/laboratory 3/115 (2.6%) 1/38 (2.6%)
    Potassium, serum high 1/115 (0.9%) 1/38 (2.6%)
    Potassium, serum low 3/115 (2.6%) 0/38 (0%)
    Musculoskeletal and connective tissue disorders
    Muscle weakness 2/115 (1.7%) 1/38 (2.6%)
    Arthritis 1/115 (0.9%) 0/38 (0%)
    Rhabdomyolysis 1/115 (0.9%) 0/38 (0%)
    Abdomen nos 78/115 (67.8%) 19/38 (50%)
    Back 9/115 (7.8%) 7/38 (18.4%)
    Bone 4/115 (3.5%) 0/38 (0%)
    Joint 2/115 (1.7%) 0/38 (0%)
    Muscle 5/115 (4.3%) 6/38 (15.8%)
    Neck 1/115 (0.9%) 0/38 (0%)
    Neck/back 0/115 (0%) 1/38 (2.6%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tumor pain 4/115 (3.5%) 2/38 (5.3%)
    Nervous system disorders
    Dysgeusia 4/115 (3.5%) 5/38 (13.2%)
    Tremor 2/115 (1.7%) 0/38 (0%)
    Neuropathy 6/115 (5.2%) 1/38 (2.6%)
    Dizziness 3/115 (2.6%) 2/38 (5.3%)
    Extrapyramidal 0/115 (0%) 1/38 (2.6%)
    Somnolence 4/115 (3.5%) 0/38 (0%)
    Headache 6/115 (5.2%) 1/38 (2.6%)
    Psychiatric disorders
    Insomnia 4/115 (3.5%) 2/38 (5.3%)
    Confusion 0/115 (0%) 1/38 (2.6%)
    Personality/behavioral 19/115 (16.5%) 2/38 (5.3%)
    Renal and urinary disorders
    Genitourinary 0/115 (0%) 1/38 (2.6%)
    Kidney 1/115 (0.9%) 0/38 (0%)
    Incontinence, urinary 0/115 (0%) 1/38 (2.6%)
    Renal failure 4/115 (3.5%) 1/38 (2.6%)
    Renal/genitourinary 1/115 (0.9%) 0/38 (0%)
    Urinary retention 2/115 (1.7%) 0/38 (0%)
    Urine color change 6/115 (5.2%) 0/38 (0%)
    Reproductive system and breast disorders
    Testicular oedema 1/115 (0.9%) 0/38 (0%)
    Respiratory, thoracic and mediastinal disorders
    Hemorrhage nasal 2/115 (1.7%) 1/38 (2.6%)
    Nasal/paranasal reactions 6/115 (5.2%) 4/38 (10.5%)
    Cough 12/115 (10.4%) 4/38 (10.5%)
    Dyspnea 11/115 (9.6%) 5/38 (13.2%)
    Hiccoughs 1/115 (0.9%) 0/38 (0%)
    Pulmonay/upper respiratoy- other 1/115 (0.9%) 0/38 (0%)
    Voice changes 1/115 (0.9%) 1/38 (2.6%)
    Skin and subcutaneous tissue disorders
    Alopecia 0/115 (0%) 1/38 (2.6%)
    Cheilitis 1/115 (0.9%) 0/38 (0%)
    Dermatology/skin- other 2/115 (1.7%) 1/38 (2.6%)
    Dry skin 0/115 (0%) 1/38 (2.6%)
    Hypopigmentation 1/115 (0.9%) 0/38 (0%)
    Nail changes 2/115 (1.7%) 0/38 (0%)
    Pruritus/itching 3/115 (2.6%) 0/38 (0%)
    Rash/desquamation 1/115 (0.9%) 1/38 (2.6%)
    Surgical and medical procedures
    Upper airway nos 1/115 (0.9%) 0/38 (0%)
    Vein nos 1/115 (0.9%) 0/38 (0%)
    Vascular disorders
    Hypertension 2/115 (1.7%) 1/38 (2.6%)
    Pulmonary hypertension 0/115 (0%) 1/38 (2.6%)
    Haematoma 1/115 (0.9%) 0/38 (0%)
    Hypotension 1/115 (0.9%) 0/38 (0%)
    Phlebitis 5/115 (4.3%) 4/38 (10.5%)
    Thrombosis/embolism 7/115 (6.1%) 5/38 (13.2%)
    Thrombosis/thrombus 4/115 (3.5%) 0/38 (0%)
    Vein injury 0/115 (0%) 1/38 (2.6%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.

    Results Point of Contact

    Name/Title Medical Communications
    Organization Hoffman-LaRoche
    Phone 800-821-8590
    Email genentech@druginfo.com
    Responsible Party:
    Hoffmann-La Roche
    ClinicalTrials.gov Identifier:
    NCT00461708
    Other Study ID Numbers:
    • ML20296
    First Posted:
    Apr 18, 2007
    Last Update Posted:
    Oct 15, 2015
    Last Verified:
    Sep 1, 2015