Docetaxel and Oxaliplatin in Gastric Cancer
Sponsor
Sanofi (Industry)
Overall Status
Completed
CT.gov ID
NCT00382720
Collaborator
(none)
275
12
3
43
22.9
0.5
Study Details
Study Description
Brief Summary
This phase II study addressed the use of docetaxel in combination with oxaliplatin with or without 5-FU or capecitabine in metastatic or locally recurrent gastric cancer previously untreated with chemotherapy for advanced disease. Prior to this study a pilot phase I (part
- determined the optimal dose by assessing the safety and tolerability of 2 dose levels in each arm. The optimal dose was administered in the Part II study. Participants who received the optimal dose in each treatment arm in Part I were included in the Part II analysis population.
Primary objective:
- To assess the time to progression (TTP) of Docetaxel in combination with Oxaliplatin with or without 5-Fluorouracil (5-FU) or Capecitabine in metastatic or locally recurrent gastric cancer previously untreated with chemotherapy for advanced disease (part II).
Secondary objectives:
-
To establish the safety profile.
-
To assess the Overall Response Rate (ORR) based on the World Health Organization (WHO) criteria
-
To assess the Overall Survival (OS)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
The purpose of this study (Part II) was to evaluate the time to progression in the 3 arms at an optimal dose level of docetaxel and oxaliplatin defined during a prior pilot (Part I) phase study. The estimated duration of treatment was to be 6 months. Treatment was to be administered up to progression, unacceptable toxicities, or withdrawal of consent. The reason and date of removal of all participants was documented on the case report form.
Participants who ended treatment but had not yet progressed (e.g. unacceptable toxicities or withdrawal of consent) were be followed every 8 weeks with a complete tumor assessment until documented progression or further anti-tumor therapy. Then, they would be followed every 3 months after progression for survival status; date of death or progression were reported. Participants who ended treatment for progression, were to be followed every 3 months until death. Date of death was reported. The planned duration of the study was 30 months.
Study Design
Study Type:
Interventional
Actual Enrollment
:
275 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Phase II Study of Docetaxel in Combination With Oxaliplatin With or Without 5-FU or Capecitabine in Metastatic or Locally Recurrent Gastric Cancer Previously Untreated With Chemotherapy for Advanced Disease
Study Start Date
:
Sep 1, 2006
Actual Primary Completion Date
:
Apr 1, 2010
Actual Study Completion Date
:
Apr 1, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: TE (Taxotere and Eloxatin) Docetaxel (Taxotere) in combination with Oxaliplatin (Eloxatin). Each chemotherapy cycle was repeated every 21 days. Participants received either the optimal or non-optimal dose for Taxotere and Eloxatin. Participants who received the optimal dose for Taxotere and Eloxatin were analyzed in this study. |
Drug: Docetaxel + Oxaliplatin
Dose level 1 (non-optimal dose):
Docetaxel 75 mg/m² as an 1-hour intravenous (IV) infusion on day 1 followed by Oxaliplatin 100 mg/m² as a two to six-hour IV infusion on day 1
Dose level 2 (optimal dose):
Docetaxel 75 mg/m² as an 1-hour IV infusion on day 1 followed by Oxaliplatin 130 mg/m² as a two to six-hour IV infusion on day 1
|
| Experimental: TEF (Taxotere, Eloxatin and 5-FU) Docetaxel (Taxotere) in combination with Oxaliplatin (Eloxatin) and 5-FU (5-Fluorouracil). Each chemotherapy cycle was repeated every 14 days. Participants received either the optimal or non-optimal dose for Taxotere, Eloxatin and 5-FU. Participants who received the optimal dose for Taxotere, Eloxatin and 5-FU were analyzed in this study. |
Drug: Docetaxel + Oxaliplatin + 5-FU
Dose level 1 (non-optimal dose):
Docetaxel 40 mg/m² as a 1-hour intravenous (IV) infusion day 1; Oxaliplatin 85 mg/m² simultaneously with folinic acid 400 mg/m² as a 2-hour IV infusion, followed by 5-FU 2400 mg/m2 as a 46-hour continuous infusion day 1.
Dose level 2 (optimal dose):
Docetaxel 50 mg/m² as a 1-hour IV infusion day 1; Oxaliplatin 85 mg/m² simultaneously with folinic acid 400 mg/m² as a 2-hour IV infusion, followed by 5-FU 2400 mg/m² as a 46-hour continuous infusion day 1.
|
| Experimental: TEX (Taxotere, Eloxatin and Xeloda) Docetaxel (Taxotere) in combination with Oxaliplatin (Eloxatin) and capecitabine (Xeloda). Each chemotherapy cycle was repeated every 21 days. Participants received either the optimal or non-optimal dose for Taxotere, Eloxatin and Xeloda. Participants who received the optimal dose for Taxotere, Eloxatin and Xeloda were analyzed in this study. |
Drug: Docetaxel + Oxaliplatin + Capecitabine
Dose level 1 (optimal dose):
Docetaxel 50 mg/m² as a 1-hour intravenous (IV) infusion on day 1, Oxaliplatin 100 mg/m² as a two to six-hour IV infusion on day 1, Capecitabine 625 mg/m2 two times a day continuously.
Dose level 2 (non-optimal dose):
Docetaxel 65 mg/m² as a 1-hour IV infusion on day 1, Oxaliplatin 100 mg/m² as a two to six-hour IV infusion on day 1, Capecitabine 625 mg/m² two times a day continuously.
|
Outcome Measures
Primary Outcome Measures
- Time to Progression [every 8 weeks up to a maximum of 36 months]
The number of months measured from the day of randomization to the first tumor progression according to World Health Organization (WHO) criteria evaluation of cancer response, or death from any cause. WHO Criteria for Progressive Disease: ≥ 25% increase in the size of at least one bidimensionally or unidimensionally measurable lesion.
Secondary Outcome Measures
- Best Overall Response Rate (ORR) [every 8 weeks up to a maximum of 36 months]
Percentage of partial and complete responses, according to WHO criteria: Complete Response: Disappearance of all known disease, determined by 2 observations not less than 4 weeks apart. Partial Response: Decrease by at least 50% of the diameters of all measurable lesions, determined by 2 observations not less than 4 weeks apart.
- Overall Survival (OS) [up to a maximum of 36 months]
The number of months measured from the date of randomization to the date of death due to any cause.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion criteria:
-
Histologically proven gastric adenocarcinoma, including adenocarcinoma of the gastro-oesophageal junction
-
Metastatic or locally recurrent disease
-
Prior adjuvant (and/or neo-adjuvant) chemotherapy with 5-Fluorouracil, Cisplatin, epirubicin is allowed provided that the patient has relapsed > 12 months after the end of the chemotherapy
-
Performance status Karnofsky index > 70
-
Hematology within 7 days before randomization:Hemoglobin ≥10g/dl, Absolute Neutrophil Count ≥2.0 109/L, platelets ≥100 x 109/L
-
Blood chemistry within 7 days before randomization:Total bilirubin ≤1x Upper Normal Limit(UNL), Aspartate Aminotransferase (AST) Serum Glutamic Oxaloacetic Transaminase SGOT) and Alanine Aminotransferase (ALT)Serum Glutamate Pyruvate Transaminase(SGPT) ≤2.5xUNL, alkaline phosphatase ≤ 5x UNL, provided that AST or ALT > 1.5 x UNL is not associated with alkaline phosphatase > 2.5 x UNL; creatinine ≤1.25x UNL or 1.25x UNL < creatinine ≤1.5x UNL and calculated/measured creatinine clearance ≥60 ml/min)
-
Measurable and/or evaluable metastatic disease
Exclusion criteria:
-
Any prior palliative chemotherapy
-
Neurosensory symptoms National Cancer Institute Common Toxicity Criteria for Adverse Events grade≥2
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sanofi-Aventis Administrative Office | Bridgewater | New Jersey | United States | |
| 2 | Sanofi-Aventis Administrative Office | Diegem | Belgium | ||
| 3 | Sanofi-Aventis Administrative Office | Paris | France | ||
| 4 | Sanofi-Aventis Administrative Office | Frankfurt | Germany | ||
| 5 | Sanofi-Aventis Administrative Office | Budapest | Hungary | ||
| 6 | Sanofi-Aventis Administrative Office | Milan | Italy | ||
| 7 | Sanofi-Aventis Administrative Office | Porto Salvo | Portugal | ||
| 8 | Sanofi-Aventis Administrative Office | Moscow | Russian Federation | ||
| 9 | Sanofi-Aventis Administrative Office | Barcelona | Spain | ||
| 10 | Sanofi-Aventis Administrative Office | Genève | Switzerland | ||
| 11 | Sanofi-Aventis Administrative Office | Istanbul | Turkey | ||
| 12 | Sanofi-Aventis Administrative Office | Guildford Surrey | United Kingdom |
Sponsors and Collaborators
- Sanofi
Investigators
- Study Director: Jean-Philippe Aussel, Sanofi
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Sanofi
ClinicalTrials.gov Identifier:
NCT00382720
Other Study ID Numbers:
- DOCOX_C_00082
- EudraCT # : 2005-005464-92
First Posted:
Sep 29, 2006
Last Update Posted:
Jan 7, 2013
Last Verified:
Dec 1, 2012
Study Results
Participant Flow
| Recruitment Details | A total 275 participants from 12 countries were randomized in the part I/II study. 64 participants were enrolled in Part I. 211 new participants were enrolled specifically for Part II. |
|---|---|
| Pre-assignment Detail | The intent-to-treat (ITT) population, included 254 participants randomized to the optimal dose of study medication from Parts I (43) and II (211), and excluded 21 participants administered the non-optimal dose in Part I. |
| Arm/Group Title | (TE) Taxotere and Eloxatin | (TEF) Taxotere, Eloxatin and 5-fluorouracil | (TEX) Taxotere, Eloxatin and Xeloda |
|---|---|---|---|
| Arm/Group Description | Participants administered Docetaxel (Taxotere) 75 mg/m² as an 1-hour IV infusion on day 1 followed by Oxaliplatin (Eloxatin) 130 mg/m² as a two to six-hour IV infusion on day 1 per chemotherapy cycle. | Participants administed with Docetaxel (Taxotere) 50 mg/m² as a 1-hour IV infusion day 1; Oxaliplatin (Eloxatin) 85 mg/m² simultaneously with folinic acid 400 mg/m² as a 2-hour IV infusion, followed by 5-FU 2400 mg/m² as a 46-hour continuous infusion day 1 per chemotherapy cycle. | Participants administered Docetaxel (Taxotere) 50 mg/m² as a 1-hour intravenous (IV) infusion on day 1, Oxaliplatin (Eloxatin) 100 mg/m² as a two to six-hour IV infusion on day 1, Capecitabine (Xeloda) 625 mg/m2 two times a day continuously per chemotherapy cycle. |
| Period Title: Overall Study | |||
| STARTED | 79 | 89 | 86 |
| Administered Non-Optimal Dose (Part I) | 10 | 11 | 0 |
| Administered Optimal Dose (Parts I & II) | 78 | 88 | 82 |
| Full Analysis Population (FAP) | 78 | 88 | 82 |
| COMPLETED | 0 | 0 | 0 |
| NOT COMPLETED | 79 | 89 | 86 |
Baseline Characteristics
| Arm/Group Title | (TE) Taxotere and Eloxatin | (TEF) Taxotere, Eloxatin and 5-fluorouracil | (TEX) Taxotere, Eloxatin and Xeloda | Total |
|---|---|---|---|---|
| Arm/Group Description | Participants administered Docetaxel (Taxotere) 75 mg/m² as an 1-hour IV infusion on day 1 followed by Oxaliplatin (Eloxatin) 130 mg/m² as a two to six-hour IV infusion on day 1 per chemotherapy cycle. | Participants administed with Docetaxel (Taxotere) 50 mg/m² as a 1-hour IV infusion day 1; Oxaliplatin (Eloxatin) 85 mg/m² simultaneously with folinic acid 400 mg/m² as a 2-hour IV infusion, followed by 5-FU 2400 mg/m² as a 46-hour continuous infusion day 1 per chemotherapy cycle. | Participants administered Docetaxel (Taxotere) 50 mg/m² as a 1-hour intravenous (IV) infusion on day 1, Oxaliplatin (Eloxatin) 100 mg/m² as a two to six-hour IV infusion on day 1, Capecitabine (Xeloda) 625 mg/m2 two times a day continuously per chemotherapy cycle. | Total of all reporting groups |
| Overall Participants | 79 | 89 | 86 | 254 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
59.2
(11.4)
|
57.9
(11.1)
|
59.0
(11.0)
|
58.7
(11.1)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
28
35.4%
|
28
31.5%
|
22
25.6%
|
78
30.7%
|
| Male |
51
64.6%
|
61
68.5%
|
64
74.4%
|
176
69.3%
|
| Race/Ethnicity, Customized (participants) [Number] | ||||
| Asian/Oriental |
0
0%
|
1
1.1%
|
0
0%
|
1
0.4%
|
| Black |
1
1.3%
|
0
0%
|
0
0%
|
1
0.4%
|
| White |
77
97.5%
|
87
97.8%
|
84
97.7%
|
248
97.6%
|
| Unknown or Not Reported |
1
1.3%
|
1
1.1%
|
2
2.3%
|
4
1.6%
|
| Karnofsky Performance Status (KPS) (participants) [Number] | ||||
| 100% Normal, no complaints: no evidence of disease |
19
24.1%
|
28
31.5%
|
19
22.1%
|
66
26%
|
| 90% Able to carry on normal activity; minor signs |
26
32.9%
|
35
39.3%
|
31
36%
|
92
36.2%
|
| 80% Normal activity with effort, some signs |
31
39.2%
|
24
27%
|
33
38.4%
|
88
34.6%
|
| 70% Cares for self but unable to work |
1
1.3%
|
2
2.2%
|
3
3.5%
|
6
2.4%
|
| <70% Requires assistance |
1
1.3%
|
0
0%
|
0
0%
|
1
0.4%
|
| Missing |
1
1.3%
|
0
0%
|
0
0%
|
1
0.4%
|
| Weight loss during last 3 months (participants) [Number] | ||||
| less than or equal to 5% |
39
49.4%
|
47
52.8%
|
44
51.2%
|
130
51.2%
|
| greater than 5% |
39
49.4%
|
42
47.2%
|
41
47.7%
|
122
48%
|
| Missing |
1
1.3%
|
0
0%
|
1
1.2%
|
2
0.8%
|
Outcome Measures
| Title | Time to Progression |
|---|---|
| Description | The number of months measured from the day of randomization to the first tumor progression according to World Health Organization (WHO) criteria evaluation of cancer response, or death from any cause. WHO Criteria for Progressive Disease: ≥ 25% increase in the size of at least one bidimensionally or unidimensionally measurable lesion. |
| Time Frame | every 8 weeks up to a maximum of 36 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 248 participants in the full analysis population (FAP). |
| Arm/Group Title | (TE) Taxotere and Eloxatin | (TEF) Taxotere, Eloxatin and 5-fluorouracil | (TEX) Taxotere, Eloxatin and Xeloda |
|---|---|---|---|
| Arm/Group Description | Participants administered Docetaxel (Taxotere) 75 mg/m² as an 1-hour IV infusion on day 1 followed by Oxaliplatin (Eloxatin) 130 mg/m² as a two to six-hour IV infusion on day 1 per chemotherapy cycle. | Participants administed with Docetaxel (Taxotere) 50 mg/m² as a 1-hour IV infusion day 1; Oxaliplatin (Eloxatin) 85 mg/m² simultaneously with folinic acid 400 mg/m² as a 2-hour IV infusion, followed by 5-FU 2400 mg/m² as a 46-hour continuous infusion day 1 per chemotherapy cycle. | Participants administered Docetaxel (Taxotere) 50 mg/m² as a 1-hour intravenous (IV) infusion on day 1, Oxaliplatin (Eloxatin) 100 mg/m² as a two to six-hour IV infusion on day 1, Capecitabine (Xeloda) 625 mg/m2 two times a day continuously per chemotherapy cycle. |
| Measure Participants | 78 | 88 | 82 |
| Median (95% Confidence Interval) [Months] |
4.50
|
7.66
|
5.55
|
| Title | Best Overall Response Rate (ORR) |
|---|---|
| Description | Percentage of partial and complete responses, according to WHO criteria: Complete Response: Disappearance of all known disease, determined by 2 observations not less than 4 weeks apart. Partial Response: Decrease by at least 50% of the diameters of all measurable lesions, determined by 2 observations not less than 4 weeks apart. |
| Time Frame | every 8 weeks up to a maximum of 36 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 248 participants in the full analysis population (FAP). |
| Arm/Group Title | (TE) Taxotere and Eloxatin | (TEF) Taxotere, Eloxatin and 5-fluorouracil | (TEX) Taxotere, Eloxatin and Xeloda |
|---|---|---|---|
| Arm/Group Description | Participants administered Docetaxel (Taxotere) 75 mg/m² as an 1-hour IV infusion on day 1 followed by Oxaliplatin (Eloxatin) 130 mg/m² as a two to six-hour IV infusion on day 1 per chemotherapy cycle. | Participants administed with Docetaxel (Taxotere) 50 mg/m² as a 1-hour IV infusion day 1; Oxaliplatin (Eloxatin) 85 mg/m² simultaneously with folinic acid 400 mg/m² as a 2-hour IV infusion, followed by 5-FU 2400 mg/m² as a 46-hour continuous infusion day 1 per chemotherapy cycle. | Participants administered Docetaxel (Taxotere) 50 mg/m² as a 1-hour intravenous (IV) infusion on day 1, Oxaliplatin (Eloxatin) 100 mg/m² as a two to six-hour IV infusion on day 1, Capecitabine (Xeloda) 625 mg/m2 two times a day continuously per chemotherapy cycle. |
| Measure Participants | 78 | 88 | 82 |
| Number (95% Confidence Interval) [percentage of participants] |
23.1
29.2%
|
46.6
52.4%
|
25.6
29.8%
|
| Title | Overall Survival (OS) |
|---|---|
| Description | The number of months measured from the date of randomization to the date of death due to any cause. |
| Time Frame | up to a maximum of 36 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 248 participants in the full analysis population (FAP). |
| Arm/Group Title | (TE) Taxotere and Eloxatin | (TEF) Taxotere, Eloxatin and 5-fluorouracil | (TEX) Taxotere, Eloxatin and Xeloda |
|---|---|---|---|
| Arm/Group Description | Participants administered Docetaxel (Taxotere) 75 mg/m² as an 1-hour IV infusion on day 1 followed by Oxaliplatin (Eloxatin) 130 mg/m² as a two to six-hour IV infusion on day 1 per chemotherapy cycle. | Participants administed with Docetaxel (Taxotere) 50 mg/m² as a 1-hour IV infusion day 1; Oxaliplatin (Eloxatin) 85 mg/m² simultaneously with folinic acid 400 mg/m² as a 2-hour IV infusion, followed by 5-FU 2400 mg/m² as a 46-hour continuous infusion day 1 per chemotherapy cycle. | Participants administered Docetaxel (Taxotere) 50 mg/m² as a 1-hour intravenous (IV) infusion on day 1, Oxaliplatin (Eloxatin) 100 mg/m² as a two to six-hour IV infusion on day 1, Capecitabine (Xeloda) 625 mg/m2 two times a day continuously per chemotherapy cycle. |
| Measure Participants | 78 | 88 | 82 |
| Median (95% Confidence Interval) [months] |
8.97
|
14.59
|
11.30
|
Adverse Events
| Time Frame | ||||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | 248 participants in the full analysis population (FAP) were analyzed for safety. | |||||
| Arm/Group Title | (TE) Taxotere and Eloxatin | (TEF) Taxotere, Eloxatin and 5-fluorouracil | (TEX) Taxotere, Eloxatin and Xeloda | |||
| Arm/Group Description | Participants administered Docetaxel (Taxotere) 75 mg/m² as an 1-hour IV infusion on day 1 followed by Oxaliplatin (Eloxatin) 130 mg/m² as a two to six-hour IV infusion on day 1 per chemotherapy cycle. | Participants administed with Docetaxel (Taxotere) 50 mg/m² as a 1-hour IV infusion day 1; Oxaliplatin (Eloxatin) 85 mg/m² simultaneously with folinic acid 400 mg/m² as a 2-hour IV infusion, followed by 5-FU 2400 mg/m² as a 46-hour continuous infusion day 1 per chemotherapy cycle. | Participants administered Docetaxel (Taxotere) 50 mg/m² as a 1-hour intravenous (IV) infusion on day 1, Oxaliplatin (Eloxatin) 100 mg/m² as a two to six-hour IV infusion on day 1, Capecitabine (Xeloda) 625 mg/m2 two times a day continuously per chemotherapy cycle. | |||
All Cause Mortality |
||||||
| (TE) Taxotere and Eloxatin | (TEF) Taxotere, Eloxatin and 5-fluorouracil | (TEX) Taxotere, Eloxatin and Xeloda | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| (TE) Taxotere and Eloxatin | (TEF) Taxotere, Eloxatin and 5-fluorouracil | (TEX) Taxotere, Eloxatin and Xeloda | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 35/78 (44.9%) | 24/88 (27.3%) | 36/82 (43.9%) | |||
| Blood and lymphatic system disorders | ||||||
| febrile neutropenia | 7/78 (9%) | 2/88 (2.3%) | 5/82 (6.1%) | |||
| anemia | 2/78 (2.6%) | 0/88 (0%) | 1/82 (1.2%) | |||
| neutropenia | 1/78 (1.3%) | 1/88 (1.1%) | 1/82 (1.2%) | |||
| disseminated intravascular coagulation | 0/78 (0%) | 1/88 (1.1%) | 0/82 (0%) | |||
| leukopenia | 0/78 (0%) | 1/88 (1.1%) | 0/82 (0%) | |||
| Cardiac disorders | ||||||
| myocardial infarction | 1/78 (1.3%) | 0/88 (0%) | 1/82 (1.2%) | |||
| cardiac failure | 0/78 (0%) | 1/88 (1.1%) | 0/82 (0%) | |||
| cardiac failure congestive | 1/78 (1.3%) | 0/88 (0%) | 0/82 (0%) | |||
| cardiopulmonary failure | 1/78 (1.3%) | 0/88 (0%) | 0/82 (0%) | |||
| Congenital, familial and genetic disorders | ||||||
| pyloric stenosis | 0/78 (0%) | 1/88 (1.1%) | 0/82 (0%) | |||
| investigations | 0/78 (0%) | 0/88 (0%) | 1/82 (1.2%) | |||
| hemoglobin decreased | 0/78 (0%) | 0/88 (0%) | 1/82 (1.2%) | |||
| Gastrointestinal disorders | ||||||
| diarrhea | 7/78 (9%) | 3/88 (3.4%) | 2/82 (2.4%) | |||
| vomiting | 2/78 (2.6%) | 3/88 (3.4%) | 3/82 (3.7%) | |||
| abdominal pain | 1/78 (1.3%) | 1/88 (1.1%) | 2/82 (2.4%) | |||
| dysphagia | 1/78 (1.3%) | 0/88 (0%) | 2/82 (2.4%) | |||
| nausea | 0/78 (0%) | 1/88 (1.1%) | 2/82 (2.4%) | |||
| ascites | 0/78 (0%) | 0/88 (0%) | 2/82 (2.4%) | |||
| gastric perforation | 0/78 (0%) | 1/88 (1.1%) | 1/82 (1.2%) | |||
| intestinal obstruction | 1/78 (1.3%) | 0/88 (0%) | 1/82 (1.2%) | |||
| upper gastrointestinal hemorrhage | 0/78 (0%) | 2/88 (2.3%) | 0/82 (0%) | |||
| abdominal pain upper | 0/78 (0%) | 1/88 (1.1%) | 0/82 (0%) | |||
| colitis | 1/78 (1.3%) | 0/88 (0%) | 0/82 (0%) | |||
| enterocolitis | 0/78 (0%) | 0/88 (0%) | 1/82 (1.2%) | |||
| gastric hemorrhage | 1/78 (1.3%) | 0/88 (0%) | 0/82 (0%) | |||
| gastric ulcer perforation | 0/78 (0%) | 0/88 (0%) | 1/82 (1.2%) | |||
| gastrointestinal hemorrhage | 0/78 (0%) | 0/88 (0%) | 1/82 (1.2%) | |||
| hematemesis | 0/78 (0%) | 0/88 (0%) | 1/82 (1.2%) | |||
| ileus | 0/78 (0%) | 1/88 (1.1%) | 0/82 (0%) | |||
| inguinal hernia | 0/78 (0%) | 0/88 (0%) | 1/82 (1.2%) | |||
| intestinal perforation | 0/78 (0%) | 0/88 (0%) | 1/82 (1.2%) | |||
| mechanical ileus | 1/78 (1.3%) | 0/88 (0%) | 0/82 (0%) | |||
| rectal obstruction | 0/78 (0%) | 1/88 (1.1%) | 0/82 (0%) | |||
| volvulus | 0/78 (0%) | 1/88 (1.1%) | 0/82 (0%) | |||
| General disorders | ||||||
| general physical health deterioration | 3/78 (3.8%) | 1/88 (1.1%) | 1/82 (1.2%) | |||
| pyrexia | 2/78 (2.6%) | 1/88 (1.1%) | 0/82 (0%) | |||
| implant site reaction | 0/78 (0%) | 0/88 (0%) | 2/82 (2.4%) | |||
| mucosal inflammation | 0/78 (0%) | 0/88 (0%) | 2/82 (2.4%) | |||
| performance status decreased | 1/78 (1.3%) | 0/88 (0%) | 1/82 (1.2%) | |||
| asthenia | 0/78 (0%) | 0/88 (0%) | 1/82 (1.2%) | |||
| chest pain | 0/78 (0%) | 1/88 (1.1%) | 0/82 (0%) | |||
| device occlusion | 0/78 (0%) | 0/88 (0%) | 1/82 (1.2%) | |||
| fatigue | 0/78 (0%) | 0/88 (0%) | 1/82 (1.2%) | |||
| generalised edema | 0/78 (0%) | 1/88 (1.1%) | 0/82 (0%) | |||
| Hepatobiliary disorders | ||||||
| cholecystitis | 0/78 (0%) | 0/88 (0%) | 1/82 (1.2%) | |||
| cholecystitis acute | 0/78 (0%) | 0/88 (0%) | 1/82 (1.2%) | |||
| hyperbilirubinemia | 1/78 (1.3%) | 0/88 (0%) | 0/82 (0%) | |||
| Infections and infestations | ||||||
| device related infection | 0/78 (0%) | 1/88 (1.1%) | 1/82 (1.2%) | |||
| gastroenteritis | 2/78 (2.6%) | 0/88 (0%) | 0/82 (0%) | |||
| pneumonia | 0/78 (0%) | 1/88 (1.1%) | 1/82 (1.2%) | |||
| abdominal wall abscess | 0/78 (0%) | 0/88 (0%) | 1/82 (1.2%) | |||
| bronchopneumonia | 1/78 (1.3%) | 0/88 (0%) | 0/82 (0%) | |||
| clostridium difficile colitis | 0/78 (0%) | 1/88 (1.1%) | 0/82 (0%) | |||
| device related sepsis | 0/78 (0%) | 0/88 (0%) | 1/82 (1.2%) | |||
| infection | 0/78 (0%) | 1/88 (1.1%) | 0/82 (0%) | |||
| neutropenic sepsis | 1/78 (1.3%) | 0/88 (0%) | 0/82 (0%) | |||
| pelvic abscess | 0/78 (0%) | 1/88 (1.1%) | 0/82 (0%) | |||
| peritoneal abscess | 0/78 (0%) | 1/88 (1.1%) | 0/82 (0%) | |||
| sepsis | 1/78 (1.3%) | 0/88 (0%) | 0/82 (0%) | |||
| septic arthritis staphylococcal | 1/78 (1.3%) | 0/88 (0%) | 0/82 (0%) | |||
| staphylococcal sepsis | 0/78 (0%) | 0/88 (0%) | 1/82 (1.2%) | |||
| Metabolism and nutrition disorders | ||||||
| decreased appetite | 0/78 (0%) | 0/88 (0%) | 3/82 (3.7%) | |||
| dehydration | 2/78 (2.6%) | 0/88 (0%) | 1/82 (1.2%) | |||
| cachexia | 0/78 (0%) | 0/88 (0%) | 1/82 (1.2%) | |||
| hyperkalemia | 1/78 (1.3%) | 0/88 (0%) | 0/82 (0%) | |||
| hyponatremia | 1/78 (1.3%) | 0/88 (0%) | 0/82 (0%) | |||
| hypovolemia | 0/78 (0%) | 0/88 (0%) | 1/82 (1.2%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| back pain | 0/78 (0%) | 1/88 (1.1%) | 0/82 (0%) | |||
| spondylolisthesis | 1/78 (1.3%) | 0/88 (0%) | 0/82 (0%) | |||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| malignant pleural effusion | 0/78 (0%) | 0/88 (0%) | 1/82 (1.2%) | |||
| metastases to ovary | 0/78 (0%) | 0/88 (0%) | 1/82 (1.2%) | |||
| Nervous system disorders | ||||||
| ataxia | 1/78 (1.3%) | 0/88 (0%) | 0/82 (0%) | |||
| facial paresis | 0/78 (0%) | 1/88 (1.1%) | 0/82 (0%) | |||
| headache | 1/78 (1.3%) | 0/88 (0%) | 0/82 (0%) | |||
| peripheral motor neuropathy | 0/78 (0%) | 0/88 (0%) | 1/82 (1.2%) | |||
| syncope | 0/78 (0%) | 0/88 (0%) | 1/82 (1.2%) | |||
| Renal and urinary disorders | ||||||
| renal failure acute | 1/78 (1.3%) | 0/88 (0%) | 1/82 (1.2%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| pulmonary embolism | 4/78 (5.1%) | 1/88 (1.1%) | 2/82 (2.4%) | |||
| pleural effusion | 1/78 (1.3%) | 1/88 (1.1%) | 0/82 (0%) | |||
| acute pulmonary edema | 0/78 (0%) | 1/88 (1.1%) | 0/82 (0%) | |||
| aspiration | 0/78 (0%) | 0/88 (0%) | 1/82 (1.2%) | |||
| dysesthesia pharynx | 1/78 (1.3%) | 0/88 (0%) | 0/82 (0%) | |||
| respiratory arrest | 0/78 (0%) | 0/88 (0%) | 1/82 (1.2%) | |||
| respiratory failure | 0/78 (0%) | 0/88 (0%) | 1/82 (1.2%) | |||
| Vascular disorders | ||||||
| deep vein thromosis | 2/78 (2.6%) | 1/88 (1.1%) | 0/82 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| (TE) Taxotere and Eloxatin | (TEF) Taxotere, Eloxatin and 5-fluorouracil | (TEX) Taxotere, Eloxatin and Xeloda | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 75/78 (96.2%) | 87/88 (98.9%) | 77/82 (93.9%) | |||
| Blood and lymphatic system disorders | ||||||
| neutropenia | 1/78 (1.3%) | 5/88 (5.7%) | 1/82 (1.2%) | |||
| febrile neutropenia | 4/78 (5.1%) | 0/88 (0%) | 1/82 (1.2%) | |||
| Gastrointestinal disorders | ||||||
| diarrhoea | 48/78 (61.5%) | 59/88 (67%) | 53/82 (64.6%) | |||
| nausea | 45/78 (57.7%) | 52/88 (59.1%) | 43/82 (52.4%) | |||
| vomiting | 36/78 (46.2%) | 30/88 (34.1%) | 30/82 (36.6%) | |||
| stomatitis | 19/78 (24.4%) | 39/88 (44.3%) | 21/82 (25.6%) | |||
| abdominal pain | 24/78 (30.8%) | 19/88 (21.6%) | 16/82 (19.5%) | |||
| constipation | 13/78 (16.7%) | 15/88 (17%) | 20/82 (24.4%) | |||
| abdominal pain upper | 7/78 (9%) | 12/88 (13.6%) | 9/82 (11%) | |||
| dyspepsia | 3/78 (3.8%) | 7/88 (8%) | 12/82 (14.6%) | |||
| dysphagia | 6/78 (7.7%) | 5/88 (5.7%) | 10/82 (12.2%) | |||
| abdominal distension | 2/78 (2.6%) | 4/88 (4.5%) | 5/82 (6.1%) | |||
| oral pain | 4/78 (5.1%) | 0/88 (0%) | 1/82 (1.2%) | |||
| General disorders | ||||||
| fatigue | 35/78 (44.9%) | 45/88 (51.1%) | 39/82 (47.6%) | |||
| asthenia | 21/78 (26.9%) | 22/88 (25%) | 16/82 (19.5%) | |||
| pyrexia | 12/78 (15.4%) | 12/88 (13.6%) | 9/82 (11%) | |||
| oedema peripheral | 8/78 (10.3%) | 10/88 (11.4%) | 12/82 (14.6%) | |||
| mucosal inflammation | 1/78 (1.3%) | 6/88 (6.8%) | 2/82 (2.4%) | |||
| oedema | 5/78 (6.4%) | 3/88 (3.4%) | 1/82 (1.2%) | |||
| Investigations | ||||||
| weight decreased | 5/78 (6.4%) | 7/88 (8%) | 8/82 (9.8%) | |||
| Metabolism and nutrition disorders | ||||||
| decreased appetite | 32/78 (41%) | 36/88 (40.9%) | 37/82 (45.1%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| back pain | 6/78 (7.7%) | 4/88 (4.5%) | 9/82 (11%) | |||
| pain in extremity | 5/78 (6.4%) | 6/88 (6.8%) | 3/82 (3.7%) | |||
| Nervous system disorders | ||||||
| peripheral sensory neuropathy | 27/78 (34.6%) | 33/88 (37.5%) | 25/82 (30.5%) | |||
| neuropathy peripheral | 12/78 (15.4%) | 19/88 (21.6%) | 19/82 (23.2%) | |||
| dysgeusia | 5/78 (6.4%) | 23/88 (26.1%) | 12/82 (14.6%) | |||
| paraesthesia | 11/78 (14.1%) | 16/88 (18.2%) | 6/82 (7.3%) | |||
| dizziness | 7/78 (9%) | 7/88 (8%) | 4/82 (4.9%) | |||
| headache | 4/78 (5.1%) | 6/88 (6.8%) | 8/82 (9.8%) | |||
| dysaesthesia | 2/78 (2.6%) | 1/88 (1.1%) | 6/82 (7.3%) | |||
| neurotoxicity | 4/78 (5.1%) | 3/88 (3.4%) | 0/82 (0%) | |||
| Psychiatric disorders | ||||||
| insomnia | 8/78 (10.3%) | 4/88 (4.5%) | 8/82 (9.8%) | |||
| anxiety | 4/78 (5.1%) | 2/88 (2.3%) | 3/82 (3.7%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| dyspnoea | 16/78 (20.5%) | 11/88 (12.5%) | 9/82 (11%) | |||
| cough | 5/78 (6.4%) | 9/88 (10.2%) | 5/82 (6.1%) | |||
| epistaxis | 1/78 (1.3%) | 10/88 (11.4%) | 1/82 (1.2%) | |||
| oropharyngeal pain | 2/78 (2.6%) | 6/88 (6.8%) | 3/82 (3.7%) | |||
| hiccups | 2/78 (2.6%) | 2/88 (2.3%) | 6/82 (7.3%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| alopecia | 25/78 (32.1%) | 47/88 (53.4%) | 36/82 (43.9%) | |||
| nail disorder | 5/78 (6.4%) | 11/88 (12.5%) | 17/82 (20.7%) | |||
| skin reaction | 4/78 (5.1%) | 5/88 (5.7%) | 13/82 (15.9%) | |||
| palmar-plantar erythrodysaesthesia syndrome | 5/78 (6.4%) | 4/88 (4.5%) | 10/82 (12.2%) | |||
| rash | 3/78 (3.8%) | 6/88 (6.8%) | 5/82 (6.1%) | |||
| dry skin | 1/78 (1.3%) | 2/88 (2.3%) | 6/82 (7.3%) | |||
| Vascular disorders | ||||||
| hypotension | 0/78 (0%) | 3/88 (3.4%) | 5/82 (6.1%) | |||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
If no publication has occurred within 12 months after trial completion, the Investigator can publish the results. Prior to publication, the sponsor shall review the manuscript and can request changes, provided they do not jeopardize the accuracy and/or the scientific value of the publication. The approval is given in writing by the sponsor, not exceeding 90 days.
Results Point of Contact
| Name/Title | International Clinical Development Clinical Study Director |
|---|---|
| Organization | sanofi-aventis |
| Phone | |
| contact-us@sanofi-aventis.com |
Responsible Party:
Sanofi
ClinicalTrials.gov Identifier:
NCT00382720
Other Study ID Numbers:
- DOCOX_C_00082
- EudraCT # : 2005-005464-92
First Posted:
Sep 29, 2006
Last Update Posted:
Jan 7, 2013
Last Verified:
Dec 1, 2012