| Study Of FOLFIRI Chemotherapy With Or Without Sunitinib In Patients With Metastatic Colorectal Cancer |
| A Multicenter, Randomised, Double-Blind, Phase 3 Study Of Sunitinib In Metastatic Colorectal Cancer Patients Receiving Irinotecan, 5-Fluorouracil And Leucovorin (FOLFIRI) As First Line Treatment |
| The purpose of the study is to evaluate the safety and efficacy of FOLFIRI (Irinotecan, Leucovorin and 5 Fluorouracil) chemotherapy when combined with sunitinib or FOLFIRI chemotherapy without adding sunitinib as the first line treatment of patients with metastatic colorectal cancer. |
| On June 25, 2009, the independent Data Monitoring Committee (DMC) reviewed the progress of Study A6181122. The DMC determined Study A6181122 had met pre-specified futility criteria and was unlikely to meet its primary endpoint to demonstrate a statistically significant improvement in progression-free survival (PFS) in patients treated with sunitinib plus FOLFIRI versus placebo plus FOLFIRI. No new safety findings were noted. Pfizer notified clinical trial investigators involved in the study and regulatory agencies of these findings. Patients receiving benefit on treatment as determined by the investigator may remain on study. |
| Interventional |
| Phase 3 |
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment |
| Metastatic Colorectal Cancer |
- Drug: 5 fluorouracil
400mg/m2 bolus injection day 1 followed by 2400mg/m2 continuous infusion for 46 hours every 14 days
- Drug: irinotecan
180mg/m2 iv day 1 every 14 days
- Drug: levo- leucovorin
200mg/m2 iv; day 1 every 14 days
- Drug: sunitinib
37.5mg of blinded therapy every day for 28 days followed by 14 days of blinded therapy free period
- Drug: placebo
37.5mg of blinded placebo therapy every day for 28 days followed by 14 days of blinded therapy free period
|
- Experimental: 1
Interventions:
- Drug: 5 fluorouracil
- Drug: irinotecan
- Drug: levo- leucovorin
- Drug: sunitinib
- Placebo Comparator: 2
Interventions:
- Drug: 5 fluorouracil
- Drug: irinotecan
- Drug: levo- leucovorin
- Drug: placebo
|
| Carrato A, Swieboda-Sadlej A, Staszewska-Skurczynska M, Lim R, Roman L, Shparyk Y, Bondarenko I, Jonker DJ, Sun Y, De la Cruz JA, Williams JA, Korytowsky B, Christensen JG, Lin X, Tursi JM, Lechuga MJ, Van Cutsem E. Fluorouracil, leucovorin, and irinotecan plus either sunitinib or placebo in metastatic colorectal cancer: a randomized, phase III trial. J Clin Oncol. 2013 Apr 1;31(10):1341-7. doi: 10.1200/JCO.2012.45.1930. Epub 2013 Jan 28. |
| |
| Completed |
| 768 |
| March 2010 |
| March 2010 (Final data collection date for primary outcome measure) |
|
Inclusion Criteria:
- Confirmed (histologically or cytologically) colorectal adenocarcinoma with metastatic disease.
- Not received previous therapy for metastatic colorectal disease but for whom FOLFIRI treatment is clinically indicated.
- Adequate organ function defined by blood test.
Exclusion Criteria:
- History of another primary cancer in the last 3 years.
- Previous full field radiotherapy within the last 4 weeks or limited field radiotherapy within 2 weeks of enrolling into the study. Or previous radiation treatment of more that 30% of the bone marrow.
- History of presence of brain metastasis, spinal cord compression carcinomatous meningitis or leptomeningeal disease.
|
| Sexes Eligible for Study: |
All |
|
| 18 Years and older (Adult, Senior) |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, Colombia, Cyprus, Czech Republic, Germany, Hong Kong, Hungary, India, Ireland, Korea, Republic of, Mexico, Norway, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Taiwan, Thailand, Ukraine, United Kingdom |
| Former Serbia and Montenegro, Montenegro |
| |
| NCT00457691 |
| A6181122 |
| Yes |
| Not Provided |
| Not Provided |
| Director, Clinical Trial Disclosure Group, Pfizer Inc |
| Pfizer |
| Not Provided |
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
| Pfizer |
| March 2015 |
