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Trial of Poor Performance Status Patients (ToPPS)

Sponsor
SCRI Development Innovations, LLC (Other)
Overall Status
Completed
CT.gov ID
NCT00892710
Collaborator
Genentech, Inc. (Industry)
172
Enrollment
27
Locations
3
Arms
71
Duration (Months)
6.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this trial is to evaluate three treatment regimens in patients with stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) with a performance status of 2 and who were not previously treated.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

This randomized, Phase II trial will evaluate three treatment regimens in patients with previously untreated stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) and a performance status (PS) of 2. Patients will be randomized to either pemetrexed alone, pemetrexed and bevacizumab, or pemetrexed, carboplatin, and bevacizumab in a 1:1:1 fashion. All 3 regimens should be tolerable in poor performance status patients with advanced NSCLC. The 3-drug regimen (pemetrexed/carboplatin/bevacizumab) has been modified by lowering the dose of carboplatin, in order to minimize myelosuppression. This trial will be conducted at multiple study sites.

Study Design

Study Type:
Interventional
Actual Enrollment :
172 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Randomized Phase II Trial of Pemetrexed vs. Pemetrexed/Bevacizumab vs. Pemetrexed/Carboplatin/Bevacizumab in Patients With Stage IIIB/IV Non-Small-Cell Lung Cancer and ECOG Performance Status 2
Study Start Date :
Jun 1, 2009
Actual Primary Completion Date :
Jul 1, 2014
Actual Study Completion Date :
May 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pemetrexed/Bevacizumab

Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days Bevacizumab 15 mg/kg IV every 21 days

Drug: Pemetrexed
500 mg/m2 IV given over 10 minutes every 21 days
Other Names:
  • Alimta

    • Drug: Bevacizumab
    15 mg/kg IV every 21 days
    Other Names:
  • Avastin

    		•
    Experimental: Pemetrexed/Bevacizumab/Carboplatin

    Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days Bevacizumab 15 mg/kg IV every 21 days Carboplatin AUC=5 IV every 21 days

    Drug: Pemetrexed
    500 mg/m2 IV given over 10 minutes every 21 days
    Other Names:
  • Alimta

    • Drug: Bevacizumab
    15 mg/kg IV every 21 days
    Other Names:
  • Avastin

    • Drug: Carboplatin
    AUC=5 IV every 21 days
    Other Names:
  • Paraplatin

    		•
    Experimental: Pemetrexed

    Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days

    Drug: Pemetrexed
    500 mg/m2 IV given over 10 minutes every 21 days
    Other Names:
  • Alimta

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Progression Free Survival (PFS) [18 months]

      The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

    Secondary Outcome Measures

    1. Overall Response Rate (ORR), the Number of Patients Who Experience an Objective Benefit From Treatment [18 months]

      Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

    2. Time to Progression (TTP) [18 months]

      The Length of Time, in Months, That Patients Remain Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

    3. Time to Treatment Failure (TTTF) [18 months]

      Defined as the Length of Time, in Months, that Patients were Alive from the Date of First Treatment Until Treatment Discontinuation for Any Reason.

    4. Overall Survival (OS) [18 months]

      The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death

    5. 6-month and 12-month Overall Survival Probability [12 months]

      Overall Survival = The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death

    Eligibility Criteria

    Criteria

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

    1. Patients must be >=18 years of age.

    2. Non-squamous NSCLC (adenocarcinoma or large cell carcinoma). Mixed tumors with small cell anaplastic elements are not eligible. Mixed tumors with squamous histology are acceptable as long as the squamous element is not the dominant histology.

    3. Unresectable stage IIIB or stage IV disease. Stage IIIB disease should be ineligible for combined modality therapy (i.e., pleural effusions, pericardial effusions).

    4. ECOG performance status of 2.

    5. No prior systemic therapy for stage IIIB or stage IV lung cancer.

    6. Life expectancy of at least 12 weeks.

    7. Patients must have measurable disease per RECIST version 1.1 (see Section 8).

    8. Laboratory values as follows:

    • Absolute neutrophil count (ANC) ≥1500/μL

    • Hemoglobin (Hgb) ≥10 g/dL

    • Platelets ≥100,000/μL (≤7 days prior to treatment)

    • AST or ALT and alkaline phosphatase (ALP) must be <2.5 x ULN, or <5 x ULN in patients with liver metastases.

    • Total bilirubin <1.5 x the institutional ULN

    • Calculated creatinine clearance ≥45 mL/min

    1. The ability to take folic acid, Vitamin B12, and dexamethasone according to protocol.

    2. Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to start of treatment. Women of childbearing potential or men with partners of childbearing potential must use effective birth control measures during treatment. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she must agree to inform her treating physician immediately.

    3. Patient must be accessible for treatment and follow-up.

    4. Patients must be able to understand the investigational nature of this study and give written informed consent prior to study entry.

    Exclusion Criteria:

    1. Squamous cell histology. Mixed tumors will be categorized by the predominant cell type unless small cell elements are present, in which case the patient will be ineligible; sputum cytology alone is unacceptable.

    2. Patients with active brain metastases. Patients who have received radiation or surgery for brain metastases are eligible if there is no evidence of central nervous system (CNS) disease progression, and at least 2 weeks have elapsed since treatment. Ideally, patients should not still require use of seizure medication or steroids.

    3. Patients who have had major surgical procedure (not including mediastinoscopy), open biopsy, or significant traumatic injury within 4 weeks of beginning treatment; or, the anticipation of the need for major surgical procedure during the course of the study.

    4. Women who are pregnant or lactating.

    5. Minor surgical procedures (with the exception of the placement of portacath or other central venous access) must be completed at least 7 days prior to beginning protocol treatment.

    6. History of hypersensitivity to active or inactive excipients of any component of treatment (pemetrexed, bevacizumab, and/or carboplatin).

    7. Pulmonary carcinoid tumors.

    8. Patients with proteinuria at screening as demonstrated by either:

    • urine protein creatinine (UPC) ratio ≥1.0 at screening OR

    • urine dipstick for proteinuria ≥2+ (patients discovered to have ≥2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection, and must demonstrate ≤1 g of protein/24 hours to be eligible) (see Appendix B)

    1. Patients with a serious non healing wound, active ulcer, or untreated bone fracture.

    2. Patients with evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation).

    3. Patients with history of hematemesis or hemoptysis (defined as having bright red blood of ½ teaspoon or more per episode) within 1 month prior to study enrollment.

    4. History of myocardial infarction or unstable angina within 6 months of beginning treatment.

    5. Inadequately controlled hypertension (defined as systolic blood pressure >150 mmHg and /or diastolic blood pressure >100 mmHg while on antihypertensive medications).

    6. New York Heart Association (NYHA) grade II or greater congestive heart failure (CHF) (see Appendix C).

    7. Serious cardiac arrhythmia requiring medication.

    8. Significant vascular disease (e.g., aortic aneurysm requiring surgical repair, or recent peripheral arterial thrombosis) within 6 months prior to Day 1 of treatment.

    9. History of stroke or transient ischemic attack ≤ 6 months prior to beginning treatment.

    10. Any prior history of hypertensive crisis or hypertensive encephalopathy.

    11. History of abdominal fistula or gastrointestinal perforation ≤ 6 months prior to Day 1 of beginning treatment.

    12. Concurrent severe, intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.

    13. Mental condition that would prevent patient comprehension of the nature of, and risk associated with, the study.

    14. Use of any non-approved or investigational agent ≤ 30 days of administration of the first dose of study drug. Patients may not receive any other investigational or anti-cancer treatments while participating in this study.

    15. Past or current history of neoplasm other than the entry diagnosis with the exception of treated non-melanoma skin cancer or carcinoma in situ of the cervix, or other cancers cured by local therapy alone and a DFS ≥5 years.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic - AZ Scottsdale Arizona United States 85259
    2 Genesis Cancer Center Hot Springs Arkansas United States 71913
    3 Northeast Arkansas Clinic Jonesboro Arkansas United States 72401
    4 Wilshire Oncology Medical Group LaVerne California United States 91750
    5 Aventura Medical Center Aventura Florida United States 33180
    6 Collaborative Research Group/ Palm Beach Ins of Hem Onc Boynton Beach Florida United States 33435
    7 Florida Cancer Specialists Fort Myers Florida United States 33901
    8 Holy Cross Hospital Ft. Lauderdale Florida United States 33308
    9 Memorial Regional Cancer Center Hollywood Florida United States 33021
    10 Watson Clinic Center for Cancer Care and Research Lakeland Florida United States 33805
    11 Mount Sinai Comprehensive Cancer Center Miami Beach Florida United States 33140
    12 Northeast Georgia Medical Center Gainesville Georgia United States 30501
    13 University of Chicago Chicago Illinois United States 60637
    14 Northern Indiana Cancer Research Consortium South Bend Indiana United States 46601
    15 RHHP/ Hope Cancer Center Terra Haute Indiana United States 47802
    16 Hematology Oncology Associates of Northern NJ Morristown New Jersey United States 07960
    17 Oncology Hematology Care Cincinnati Ohio United States 45242
    18 Toledo Community Oncology Program Toledo Ohio United States 43617
    19 University of Pittsburgh Medical Center Pittsburgh Pennsylvania United States 15232
    20 Medical University of South Carolina Charlston South Carolina United States 29425
    21 South Carolina Oncology Associates, PA Columbia South Carolina United States 29210
    22 Spartanburg Regional Medical Center Spartanburg South Carolina United States 29303
    23 Chattanooga Oncology Hematology Associates Chattanooga Tennessee United States 37404
    24 Family Cancer Center Memphis Tennessee United States 38120
    25 Tennessee Oncology, PLLC Nashville Tennessee United States 37023
    26 The Center for Cancer and Blood Disorders Fort Worth Texas United States 76104
    27 Virginia Cancer Institute Richmond Virginia United States 23235

    Sponsors and Collaborators

    • SCRI Development Innovations, LLC
    • Genentech, Inc.

    Investigators

    • Study Chair: David Spigel, M.D., SCRI Development Innovations, LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    SCRI Development Innovations, LLC
    ClinicalTrials.gov Identifier:
    NCT00892710
    Other Study ID Numbers:
    • SCRI LUN 196
    First Posted:
    May 4, 2009
    Last Update Posted:
    May 15, 2015
    Last Verified:
    May 1, 2015
    Keywords provided by SCRI Development Innovations, LLC
    Non small cell lung cancer
    NSCLC
    Pemetrexed
    Bevacizumab
    Avastin
    Carboplatin
    Stage IIIB/IV
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung
    Bevacizumab
    Carboplatin
    Pemetrexed

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail 10 patients were enrolled/randomized, but never treated due to their reqeust, physician's request or if they were deemed ineligible. 4 of these patients were on the Pemetrexed/Bevacizumab arm and 6 were on the Pemetrexed/Bevacizumab/Carboplatin arm
    Arm/Group Title Pemetrexed Pemetrexed/Bevacizumab Pemetrexed/Bevacizumab/Carboplatin
    Arm/Group Description Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days Bevacizumab: 15 mg/kg IV every 21 days Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days Bevacizumab: 15 mg/kg IV every 21 days Carboplatin: AUC=5 IV every 21 days
    Period Title: Overall Study
    STARTED 48 59 55
    COMPLETED 0 0 0
    NOT COMPLETED 48 59 55

    Baseline Characteristics

    Arm/Group Title Pemetrexed Pemetrexed/Bevacizumab Pemetrexed/Bevacizumab/Carboplatin Total
    Arm/Group Description Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days Bevacizumab: 15 mg/kg IV every 21 days Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days Bevacizumab: 15 mg/kg IV every 21 days Carboplatin: AUC=5 IV every 21 days Total of all reporting groups
    Overall Participants 48 63 61 172
    Age (years) [Median (Full Range) ]
    Median (Full Range) [years]
    72
    72
    73
    72
    Sex: Female, Male (Count of Participants)
    Female
    18
    37.5%
    27
    42.9%
    27
    44.3%
    72
    41.9%
    Male
    30
    62.5%
    36
    57.1%
    34
    55.7%
    100
    58.1%
    Region of Enrollment (participants) [Number]
    United States
    48
    100%
    63
    100%
    61
    100%
    172
    100%

    Outcome Measures

    1. Primary Outcome
    Title Progression Free Survival (PFS)
    Description The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
    Time Frame 18 months

    Outcome Measure Data

    Analysis Population Description
    Includes all enrolled patients whether they recieved treatment or not
    Arm/Group Title Pemetrexed Pemetrexed/Bevacizumab Pemetrexed/Bevacizumab/Carboplatin
    Arm/Group Description Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days Bevacizumab: 15 mg/kg IV every 21 days Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days Bevacizumab: 15 mg/kg IV every 21 days Carboplatin: AUC=5 IV every 21 days
    Measure Participants 48 63 61
    Median (95% Confidence Interval) [months]
    2.8
    4.0
    4.8
    2. Secondary Outcome
    Title Overall Response Rate (ORR), the Number of Patients Who Experience an Objective Benefit From Treatment
    Description Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
    Time Frame 18 months

    Outcome Measure Data

    Analysis Population Description
    Includes all treated patients
    Arm/Group Title Pemetrexed Pemetrexed/Bevacizumab Pemetrexed/Bevacizumab/Carboplatin
    Arm/Group Description Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days Bevacizumab: 15 mg/kg IV every 21 days Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days Bevacizumab: 15 mg/kg IV every 21 days Carboplatin: AUC=5 IV every 21 days
    Measure Participants 48 59 55
    Number [participants]
    7
    14.6%
    18
    28.6%
    24
    39.3%
    3. Secondary Outcome
    Title Time to Progression (TTP)
    Description The Length of Time, in Months, That Patients Remain Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
    Time Frame 18 months

    Outcome Measure Data

    Analysis Population Description
    Includes all treated patients
    Arm/Group Title Pemetrexed Pemetrexed/Bevacizumab Pemetrexed/Bevacizumab/Carboplatin
    Arm/Group Description Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days Bevacizumab: 15 mg/kg IV every 21 days Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days Bevacizumab: 15 mg/kg IV every 21 days Carboplatin: AUC=5 IV every 21 days
    Measure Participants 48 59 55
    Median (95% Confidence Interval) [months]
    3.5
    5.3
    5.7
    4. Secondary Outcome
    Title Time to Treatment Failure (TTTF)
    Description Defined as the Length of Time, in Months, that Patients were Alive from the Date of First Treatment Until Treatment Discontinuation for Any Reason.
    Time Frame 18 months

    Outcome Measure Data

    Analysis Population Description
    Includes all treated patients
    Arm/Group Title Pemetrexed Pemetrexed/Bevacizumab Pemetrexed/Bevacizumab/Carboplatin
    Arm/Group Description Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days Bevacizumab: 15 mg/kg IV every 21 days Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days Bevacizumab: 15 mg/kg IV every 21 days Carboplatin: AUC=5 IV every 21 days
    Measure Participants 48 59 55
    Median (Full Range) [months]
    2.4
    3.1
    3.3
    5. Secondary Outcome
    Title Overall Survival (OS)
    Description The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
    Time Frame 18 months

    Outcome Measure Data

    Analysis Population Description
    Includes all enrolled patients, whether or not they were treated
    Arm/Group Title Pemetrexed Pemetrexed/Bevacizumab Pemetrexed/Bevacizumab/Carboplatin
    Arm/Group Description Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days Bevacizumab: 15 mg/kg IV every 21 days Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days Bevacizumab: 15 mg/kg IV every 21 days Carboplatin: AUC=5 IV every 21 days
    Measure Participants 48 63 61
    Median (95% Confidence Interval) [months]
    7.7
    8.6
    8.7
    6. Secondary Outcome
    Title 6-month and 12-month Overall Survival Probability
    Description Overall Survival = The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
    Time Frame 12 months

    Outcome Measure Data

    Analysis Population Description
    Includes all enrolled patients, whether or not they received treatment
    Arm/Group Title Pemetrexed Pemetrexed/Bevacizumab Pemetrexed/Bevacizumab/Carboplatin
    Arm/Group Description Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days Bevacizumab: 15 mg/kg IV every 21 days Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days Bevacizumab: 15 mg/kg IV every 21 days Carboplatin: AUC=5 IV every 21 days
    Measure Participants 48 63 61
    6-month OS probability
    0.52
    0.61
    0.57
    12-month OS probability
    0.3
    0.32
    0.44

    Adverse Events

    Time Frame 18 Months
    Adverse Event Reporting Description
    Arm/Group Title Pemetrexed Pemetrexed/Bevacizumab Pemetrexed/Bevacizumab/Carboplatin
    Arm/Group Description Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days Bevacizumab: 15 mg/kg IV every 21 days Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days Bevacizumab: 15 mg/kg IV every 21 days Carboplatin: AUC=5 IV every 21 days
    All Cause Mortality
    Pemetrexed Pemetrexed/Bevacizumab Pemetrexed/Bevacizumab/Carboplatin
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Pemetrexed Pemetrexed/Bevacizumab Pemetrexed/Bevacizumab/Carboplatin
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 30/48 (62.5%) 28/63 (44.4%) 33/61 (54.1%)
    Blood and lymphatic system disorders
    Anemia 1/48 (2.1%) 1/63 (1.6%) 0/61 (0%)
    Febrile Neutropenia 0/48 (0%) 2/63 (3.2%) 0/61 (0%)
    Hemolysis 0/48 (0%) 0/63 (0%) 1/61 (1.6%)
    Cardiac disorders
    Atrial Fibrillation 1/48 (2.1%) 0/63 (0%) 1/61 (1.6%)
    Atrial flutter 1/48 (2.1%) 0/63 (0%) 0/61 (0%)
    Myocardial Infarction 0/48 (0%) 0/63 (0%) 1/61 (1.6%)
    Pericardial effusion 1/48 (2.1%) 0/63 (0%) 0/61 (0%)
    Eye disorders
    Eye disorders - Other, blindness 1/48 (2.1%) 0/63 (0%) 0/61 (0%)
    Eye infection 0/48 (0%) 1/63 (1.6%) 0/61 (0%)
    Gastrointestinal disorders
    Constipation 0/48 (0%) 2/63 (3.2%) 0/61 (0%)
    Esophagitis 2/48 (4.2%) 0/63 (0%) 0/61 (0%)
    Upper gastrointestinal hemorrhage 0/48 (0%) 1/63 (1.6%) 1/61 (1.6%)
    Abdominal Pain 1/48 (2.1%) 0/63 (0%) 0/61 (0%)
    Diarrhea 0/48 (0%) 1/63 (1.6%) 0/61 (0%)
    Gastrointestinal disorders - Other, rectal fissure 0/48 (0%) 0/63 (0%) 1/61 (1.6%)
    Gastrointestinal disorders - Other, small bowel obstruction 1/48 (2.1%) 0/63 (0%) 0/61 (0%)
    Gastrointestinal disorders - Other, unspecified ulcer 0/48 (0%) 1/63 (1.6%) 0/61 (0%)
    Nausea 0/48 (0%) 1/63 (1.6%) 0/61 (0%)
    Vomiting 0/48 (0%) 1/63 (1.6%) 0/61 (0%)
    General disorders
    General disorders and administration site conditions - Other, disease progression 4/48 (8.3%) 4/63 (6.3%) 2/61 (3.3%)
    Non-cardiac chest pain 1/48 (2.1%) 2/63 (3.2%) 1/61 (1.6%)
    Fever 2/48 (4.2%) 0/63 (0%) 1/61 (1.6%)
    Fatigue 1/48 (2.1%) 0/63 (0%) 1/61 (1.6%)
    Death NOS 0/48 (0%) 1/63 (1.6%) 0/61 (0%)
    General disorders and administration site conditions - Other, failure to thrive 0/48 (0%) 1/63 (1.6%) 0/61 (0%)
    Hepatobiliary disorders
    Cholecystitis 0/48 (0%) 0/63 (0%) 1/61 (1.6%)
    Infections and infestations
    Infections and infestations - Other, pneumonia 8/48 (16.7%) 5/63 (7.9%) 4/61 (6.6%)
    Skin infection 4/48 (8.3%) 0/63 (0%) 0/61 (0%)
    Bronchial infection 0/48 (0%) 1/63 (1.6%) 0/61 (0%)
    Infections and infestations - Other, intestinal clostridium 1/48 (2.1%) 0/63 (0%) 0/61 (0%)
    Infections and infestations - Other, s. maltophilia bacteremia 0/48 (0%) 0/63 (0%) 1/61 (1.6%)
    Infections and infestations - Other, Staphylococcus Hominis Bacteremia 0/48 (0%) 1/63 (1.6%) 0/61 (0%)
    Sepsis 0/48 (0%) 0/63 (0%) 1/61 (1.6%)
    Infections and infestations - Other, gastroenteritis 0/48 (0%) 0/63 (0%) 0/61 (0%)
    Injury, poisoning and procedural complications
    Fracture 0/48 (0%) 1/63 (1.6%) 1/61 (1.6%)
    Investigations
    Investigations - Other, pancytopenia 0/48 (0%) 0/63 (0%) 2/61 (3.3%)
    Investigations - Other, transaminitis 1/48 (2.1%) 0/63 (0%) 0/61 (0%)
    Metabolism and nutrition disorders
    Dehydration 2/48 (4.2%) 1/63 (1.6%) 2/61 (3.3%)
    Acidosis 1/48 (2.1%) 0/63 (0%) 0/61 (0%)
    Hyperkalemia 1/48 (2.1%) 0/63 (0%) 0/61 (0%)
    Musculoskeletal and connective tissue disorders
    Flank pain 0/48 (0%) 1/63 (1.6%) 1/61 (1.6%)
    Pain in extremity 0/48 (0%) 0/63 (0%) 1/61 (1.6%)
    Nervous system disorders
    Seizure 0/48 (0%) 1/63 (1.6%) 1/61 (1.6%)
    Stroke 0/48 (0%) 1/63 (1.6%) 1/61 (1.6%)
    Encephalopathy 0/48 (0%) 0/63 (0%) 1/61 (1.6%)
    Somnolence 0/48 (0%) 1/63 (1.6%) 0/61 (0%)
    Syncope 1/48 (2.1%) 0/63 (0%) 0/61 (0%)
    Transient ischemic attacks 0/48 (0%) 0/63 (0%) 1/61 (1.6%)
    Psychiatric disorders
    Psychiatric disorders - Other, change in mental status 1/48 (2.1%) 1/63 (1.6%) 1/61 (1.6%)
    Confusion 0/48 (0%) 0/63 (0%) 1/61 (1.6%)
    Renal and urinary disorders
    Renal and urinary disorders - Other, renal failure 2/48 (4.2%) 0/63 (0%) 0/61 (0%)
    Respiratory, thoracic and mediastinal disorders
    Respiratory, thoracic and mediastinal disorders - Other, COPD exacerbation 2/48 (4.2%) 0/63 (0%) 5/61 (8.2%)
    Pleural Effusion 0/48 (0%) 3/63 (4.8%) 1/61 (1.6%)
    Respiratory Failure 0/48 (0%) 0/63 (0%) 4/61 (6.6%)
    Dyspnea 1/48 (2.1%) 0/63 (0%) 2/61 (3.3%)
    Adult respiratory distress syndrome 0/48 (0%) 1/63 (1.6%) 0/61 (0%)
    Cough 0/48 (0%) 0/63 (0%) 1/61 (1.6%)
    Hypoxia 0/48 (0%) 0/63 (0%) 1/61 (1.6%)
    Pneumothorax 0/48 (0%) 0/63 (0%) 1/61 (1.6%)
    Respiratory, thoracic and mediastinal disorders - Other, acute respiratory insufficiency 0/48 (0%) 1/63 (1.6%) 0/61 (0%)
    Respiratory, thoracic and mediastinal disorders - Other, respiratory distress 1/48 (2.1%) 0/63 (0%) 0/61 (0%)
    Skin and subcutaneous tissue disorders
    Rash 0/48 (0%) 1/63 (1.6%) 1/61 (1.6%)
    Vascular disorders
    Thromboembolic event 2/48 (4.2%) 1/63 (1.6%) 3/61 (4.9%)
    Hypotension 0/48 (0%) 0/63 (0%) 2/61 (3.3%)
    Hematoma 0/48 (0%) 0/63 (0%) 1/61 (1.6%)
    Vascular disorders - Other, superior vena cava stenosis 0/48 (0%) 1/63 (1.6%) 0/61 (0%)
    Other (Not Including Serious) Adverse Events
    Pemetrexed Pemetrexed/Bevacizumab Pemetrexed/Bevacizumab/Carboplatin
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 48/48 (100%) 62/63 (98.4%) 60/61 (98.4%)
    Blood and lymphatic system disorders
    Anemia 18/48 (37.5%) 18/63 (28.6%) 25/61 (41%)
    Cardiac disorders
    Cardiac Disorders - Other, Tachycardia 1/48 (2.1%) 2/63 (3.2%) 5/61 (8.2%)
    Gastrointestinal disorders
    Nausea 19/48 (39.6%) 23/63 (36.5%) 29/61 (47.5%)
    Constipation 12/48 (25%) 24/63 (38.1%) 21/61 (34.4%)
    Diarrhea 10/48 (20.8%) 11/63 (17.5%) 12/61 (19.7%)
    Vomiting 12/48 (25%) 11/63 (17.5%) 9/61 (14.8%)
    Abdominal Pain 5/48 (10.4%) 7/63 (11.1%) 8/61 (13.1%)
    Mucositis 3/48 (6.3%) 4/63 (6.3%) 9/61 (14.8%)
    Dyspepsia 3/48 (6.3%) 4/63 (6.3%) 2/61 (3.3%)
    Dysphagia 4/48 (8.3%) 3/63 (4.8%) 1/61 (1.6%)
    Oral Pain 1/48 (2.1%) 5/63 (7.9%) 2/61 (3.3%)
    General disorders
    Fatigue 29/48 (60.4%) 39/63 (61.9%) 36/61 (59%)
    Edema 11/48 (22.9%) 13/63 (20.6%) 17/61 (27.9%)
    Non-Cardiac Chest Pain 5/48 (10.4%) 6/63 (9.5%) 4/61 (6.6%)
    Fever 10/48 (20.8%) 3/63 (4.8%) 2/61 (3.3%)
    Non-Cardiac Chest Pain 5/48 (10.4%) 5/63 (7.9%) 1/61 (1.6%)
    Infections and infestations
    Infections And Infestations - Other, Pneumonia 10/48 (20.8%) 9/63 (14.3%) 5/61 (8.2%)
    Urinary Tract Infection 2/48 (4.2%) 5/63 (7.9%) 6/61 (9.8%)
    Skin Infection 6/48 (12.5%) 2/63 (3.2%) 4/61 (6.6%)
    Sinusitis 0/48 (0%) 4/63 (6.3%) 5/61 (8.2%)
    Investigations
    Platelet Count Decreased 12/48 (25%) 10/63 (15.9%) 24/61 (39.3%)
    Neutrophil Count Decreased 7/48 (14.6%) 13/63 (20.6%) 21/61 (34.4%)
    White Blood Cell Decreased 4/48 (8.3%) 11/63 (17.5%) 13/61 (21.3%)
    Weight Loss 5/48 (10.4%) 9/63 (14.3%) 11/61 (18%)
    Metabolism and nutrition disorders
    Anorexia 15/48 (31.3%) 26/63 (41.3%) 14/61 (23%)
    Dehydration 14/48 (29.2%) 11/63 (17.5%) 9/61 (14.8%)
    Hyperglycemia 5/48 (10.4%) 3/63 (4.8%) 7/61 (11.5%)
    Hypokalemia 3/48 (6.3%) 0/63 (0%) 5/61 (8.2%)
    Hyponatremia 3/48 (6.3%) 1/63 (1.6%) 4/61 (6.6%)
    Musculoskeletal and connective tissue disorders
    Generalized Muscle Weakness 8/48 (16.7%) 14/63 (22.2%) 15/61 (24.6%)
    Myalgia 4/48 (8.3%) 9/63 (14.3%) 4/61 (6.6%)
    Back Pain 7/48 (14.6%) 7/63 (11.1%) 2/61 (3.3%)
    Pain In Extremity 4/48 (8.3%) 5/63 (7.9%) 5/61 (8.2%)
    Nervous system disorders
    Headache 1/48 (2.1%) 9/63 (14.3%) 7/61 (11.5%)
    Dizziness 3/48 (6.3%) 8/63 (12.7%) 5/61 (8.2%)
    Dysgeusia 4/48 (8.3%) 5/63 (7.9%) 4/61 (6.6%)
    Peripheral Sensory Neuropathy 5/48 (10.4%) 1/63 (1.6%) 2/61 (3.3%)
    Psychiatric disorders
    Insomnia 9/48 (18.8%) 5/63 (7.9%) 4/61 (6.6%)
    Depression 5/48 (10.4%) 6/63 (9.5%) 2/61 (3.3%)
    Anxiety 5/48 (10.4%) 4/63 (6.3%) 2/61 (3.3%)
    Confusion 2/48 (4.2%) 4/63 (6.3%) 5/61 (8.2%)
    Renal and urinary disorders
    Proteinuria 0/48 (0%) 11/63 (17.5%) 8/61 (13.1%)
    Respiratory, thoracic and mediastinal disorders
    Dyspnea 14/48 (29.2%) 26/63 (41.3%) 19/61 (31.1%)
    Cough 7/48 (14.6%) 16/63 (25.4%) 16/61 (26.2%)
    Epistaxis 2/48 (4.2%) 6/63 (9.5%) 16/61 (26.2%)
    Voice Alteration 0/48 (0%) 4/63 (6.3%) 7/61 (11.5%)
    Respiratory, Thoracic And Mediastinal Disorders - Other, Copd Exacerbation 4/48 (8.3%) 4/63 (6.3%) 2/61 (3.3%)
    Skin and subcutaneous tissue disorders
    Rash 6/48 (12.5%) 8/63 (12.7%) 5/61 (8.2%)
    Vascular disorders
    Thromboembolic Event 5/48 (10.4%) 4/63 (6.3%) 11/61 (18%)
    Hypertension 0/48 (0%) 11/63 (17.5%) 6/61 (9.8%)
    Hypotension 3/48 (6.3%) 0/63 (0%) 5/61 (8.2%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

    The sponsor can review/embargo results communications prior to public release for a period that is >60 but =180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites

    Results Point of Contact

    Name/Title John D Hainsworth, MD
    Organization Sarah Cannon Research Institute
    Phone 1-877-691-7274
    Email asksarah@scresearch.net
    Responsible Party:
    SCRI Development Innovations, LLC
    ClinicalTrials.gov Identifier:
    NCT00892710
    Other Study ID Numbers:
    • SCRI LUN 196
    First Posted:
    May 4, 2009
    Last Update Posted:
    May 15, 2015
    Last Verified:
    May 1, 2015