A Study Combining FOLFOX or FOLFIRI With AG-013736 or Bevacizumab (Avastin) in Patients With Metastatic Colorectal Cancer After Failure Of One First Line Regimen
- Conditions
- Colorectal Neoplasms
- Interventions
- Registration Number
- NCT00615056
- Lead Sponsor
- Pfizer
- Brief Summary
The study is designed to demonstrate that the combination of AG-013736 with either FOLFIRI or FOLFOX is superior to FOLFIRI or FOLFOX in combination with bevacizumab (Avastin) in delaying tumor progression in the second-line treatment of patients with metastatic colorectal cancer after failure of an irinotecan or oxaliplatin-containing first-line regimen.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 171
- Histologically documented colorectal cancer plus one of the following:
- Failure of one prior irinotecan- or oxaliplatin-containing regimen, or
- Adjuvant refractory to irinotecan- or oxaliplatin-containing regimen.
- Prior treatment in first line metastatic setting with more than one regimen
- Prior irradiation of more than 25% of bone marrow.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description B Bevacizumab (avastin) Bevacizumab (avastin) C FOLFOX (oxaliplatin, leucovorin, 5-fluorouracil [5FU]) AG-013736 (axitinib) D Bevacizumab (avastin) bevacizumab (avastin) A AG-013736 (axitinib) AG-013736 (axitinib) C AG-013736 (axitinib) AG-013736 (axitinib) D FOLFOX (oxaliplatin, leucovorin, 5-fluorouracil [5FU]) bevacizumab (avastin) B FOLFIRI (irinotecan, leucovorin, 5-fluorouracil [5FU]) Bevacizumab (avastin) A FOLFIRI (irinotecan, leucovorin, 5-fluorouracil [5FU]) AG-013736 (axitinib)
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) Baseline until disease progression or discontinuation from the study due to any cause, assessed every 8 week up to 130 weeks Time in months from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \[PD\]), or from adverse event (AE) data (where the outcome was "Death").
- Secondary Outcome Measures
Name Time Method Change From Baseline in MDASI-D Symptom Interference Score at Day 1 of Cycles 2-5, Day 1 of Every Odd-numbered Cycle Throughout the Study and End of Treatment (Cycle 65) or Withdrawal Baseline, Day 1 of cycle 2-5, Day 1 of every odd-numbered cycle throughout the study and end of treatment (cycle 65) or withdrawal Symptom Interference score is comprised of the average of 6 items on feeling or function from the MDASI-D core (general activity, mood, work, relations with others, walking, and enjoyment of life) and ranges from 0 to 10. Participants were asked to rate how much symptoms have interfered in last week; each item rated from 0 to 10, with 0 = did not interfere and 10 = interfered completely. Lower scores indicated better outcome. Total average score range: 0 to 10.
Overall Survival (OS) Baseline until death or up to 1 year after the randomization of last participant Time in months from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).
Percentage of Participants With Objective Response (OR) Baseline until disease progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 130 weeks Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. PR are those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.
Duration of Response (DR) Baseline until disease progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 130 weeks Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response.
Change From Baseline in MD Anderson Symptoms Inventory Diarrhea (MDASI-D) Symptom Severity Score at Day 1 of Cycles 2-5, Day 1 of Every Odd-numbered Cycle Throughout the Study and End of Treatment (Cycle 65) or Withdrawal Baseline, Day 1 of cycles 2- 5, Day 1 of every odd-numbered cycle throughout the study and end of treatment (cycle 65) or withdrawal Symptom severity score is comprised of average of 14 MDASI-D core items (pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, remembering things, lack of appetite, drowsiness, dry mouth, sadness, vomiting, numbness or tingling and diarrhea) and ranges from 0 to 10. Participants were asked to rate severity of each symptom at their worst in last week; each item rated from 0 to 10, with 0 = symptom not present and 10 = as bad as you can imagine. Lower scores indicated better outcome. Total average score range: 0 to 10.
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇪🇸Madrid, Spain