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Colorectal

A multicenter, randomized double blind phase 3 study of sunitinib in metastatic colorectal cancer patients receiving irinotecan, 5-fluorouracil and leucovorin (FOLFIRI) as first line treatment

Unique Data Set IDColorec_Pfizer_2007_114
DownloadableYes
SponsorPfizerData ProviderPfizerTotal Study Enrolled Patients768Comparator (Control) Arm Enrolled Patients382RandomizationYesClinicalTrial.gov IDNCT00457691ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/NCT00457691?term=NCT00457691&rank=1
Study PhaseClinical Study Phase IIIBlinding MethodDouble-BlindedType(s) of dataOnly comparator arm dataIntervention TypeChemotherapy, DrugData Set TypeSDTM

Clinical Trial Title

A multicenter, randomized double blind phase 3 study of sunitinib in metastatic colorectal cancer patients receiving irinotecan, 5-fluorouracil and leucovorin (FOLFIRI) as first line treatment

Trial Summary and Conditions

This double-blind, phase III study aimed to demonstrate that sunitinib plus FOLFIRI (fluorouracil, leucovorin, and irinotecan) was superior to placebo plus FOLFIRI in previously untreated metastatic colorectal cancer

Data Summary

Following a second prespecified interim analysis, the study was stopped because of potential futility of sunitinib plus FOLFIRI. Final results are reported. The PFS hazard ratio was 1.095 (95% CI, 0.892 to 1.344; one-sided stratified log-rank P = .807), indicating a lack of superiority for sunitinib plus FOLFIRI. Median PFS for the sunitinib arm was 7.8 months (95% CI, 7.1 to 8.4 months) versus 8.4 months (95% CI, 7.6 to 9.2 months) for the placebo arm. Sunitinib plus FOLFIRI was associated with more grade ?? 3 adverse events and laboratory abnormalities than placebo (especially diarrhea, stomatitis/oral syndromes, fatigue, hand-foot syndrome, neutropenia, thrombocytopenia, anemia, and febrile neutropenia). More deaths as a result of toxicity (12 v four) and significantly more dose delays, dose reductions, and treatment discontinuations occurred in the sunitinib arm.

Study Objectives

This study was a prospective, multicenter, randomized (1:1), double-blind, placebo-controlled, parallel-arm, Phase 3 clinical trial to evaluate the efficacy and safety of sunitinib versus placebo in metastatic colorectal cancer patients receiving FOLFIRI (irinotecan, 5-FU and leucovorin) in the first-line treatment setting. Only patients for whom FOLFIRI was clinically indicated and have not been previously treated for metastatic disease were eligible to participate.

Outcome Measures

PFS, RR, safety

Available Downloads:

To gain access to the data and analytic tools click here.

PROTOCOL: A6181122 Final Protocol 28 AUGUST 2007_1.pdf

CRF: A6181122 Case Report Form.pdf

DATA DICTIONARY: A6181122_SPECS.xlsx

DATA (COMPARATOR ARM): adverse.sas7bdat

DATA (COMPARATOR ARM): cd_b_p.sas7bdat

DATA (COMPARATOR ARM): cn_6_p.sas7bdat

DATA (COMPARATOR ARM): cn_7_p.sas7bdat

DATA (COMPARATOR ARM): cn_8_p.sas7bdat

DATA (COMPARATOR ARM): condrug.sas7bdat

DATA (COMPARATOR ARM): contrt.sas7bdat

DATA (COMPARATOR ARM): demog.sas7bdat

DATA (COMPARATOR ARM): ecg.sas7bdat

DATA (COMPARATOR ARM): final.sas7bdat

DATA (COMPARATOR ARM): iota_p.sas7bdat

DATA (COMPARATOR ARM): lab_safe.sas7bdat

DATA (COMPARATOR ARM): pfm_p.sas7bdat

DATA (COMPARATOR ARM): phyexam.sas7bdat

DATA (COMPARATOR ARM): prevdis.sas7bdat

DATA (COMPARATOR ARM): primdiag.sas7bdat

DATA (COMPARATOR ARM): random.sas7bdat

DATA (COMPARATOR ARM): testdrug.sas7bdat

DATA (COMPARATOR ARM): tmm_p.sas7bdat

DATA (COMPARATOR ARM): vitals.sas7bdat