Study Of Sunitinib In Combination With Folfox In Patients With Colorectal Cancer

Phase 1

Completed

• Conditions: Colorectal Neoplasms
• Interventions: Drug: sunitinib + mFOLFOX6

• Registration Number: NCT00631410
• Lead Sponsor: Pfizer

Brief Summary

To assess the safety and tolerability of sunitinib when administered in combination with modified FOLFOX6 in Japanese patients with metastatic colorectal cancer in the first-line treatment setting.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-02
• Study First Submitted QC: 2008-02-27
• Study First Posted: 2008-03-07
• Primary Completion: 2009-07
• Study Completion: 2010-03
• Results First Submitted: 2010-07-21
• Results First Submitted QC: 2010-07-21
• Results First Posted: 2010-08-17
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-11
• Last Update Posted: 2011-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Histologically or cytologically confirmed adenocarcinoma of the colon or rectum with documented locally advanced or metastatic disease.
• Evidence of unidimensionally measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST).
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

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Exclusion Criteria

• Prior treatment with systemic therapy for locally advanced or metastatic colorectal cancer.
• Prior surgery or investigational agent within 4 weeks prior to study entry.
• Pregnancy or breastfeeding. All female patients of reproductive potential must have a negative pregnancy test (serum or urine) prior to the start of the study.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	sunitinib + mFOLFOX6	-
B	sunitinib + mFOLFOX6	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events	Up to 733 days (the last subject study discontinuation)	Number of participants with any adverse events, adverse events graded as Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE) Grade 3 or higher , serious adverse events, adverse events resulted in discontinuation, treatment interruption, or dose reduction.

Secondary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS)	Up to 733 days (the last subject study discontinuation)	Progression-free survival is defined as the time from date of enrolment to date of first documentation of progression based on investigator's assessment or death due to any cause.
Sunitinib Relative Dose Intensity in the Treatment Arm A	Up to 733 days (the last subject study discontinuation in the Treatment Arm A)	Relative dose intensity is defined as percentage of total dose administered over total dose assigned through assessment period. Period 1: Cycle 1 to 3; Period 2: Cycle 4 to 6; Period"n": Cycle (n-1)\*3+1 to n\*3.
Sunitinib Relative Dose Intensity in the Treatment Arm B	Up to 384 days (the last subject study discontinuation in the Treatment Arm B)	Relative dose intensity is defined as percentage of total dose administered over total dose assigned through assessment period. Period 1: Cycle 1 to 2; Period 2: Cycle 3 to 4, Period"n": Cycle (n-1)\*2+1 to n\*2.
Plasma Concentration of Sunitinib	Cycle 1 Day 14 and Cycle 2 Day 1	Concentrations after administration of sunitinib alone (Day 14 of Cycle 1) and those after administration of sunitinib in combination with mFOLFOX6 (Day 1 of Cycle 2) were evaluated.
Plasma Concentration of Sunitinib Active Metabolite (SU012662)	Cycle 1 Day 14 and Cycle 2 Day 1	Concentrations after administration of sunitinib alone (Day 14 of Cycle 1) and those after administration of sunitinib in combination with mFOLFOX6 (Day 1 of Cycle 2) were evaluated.
Plasma Concentration of the Total Drug (Sunitinib Plus SU012662)	Cycle 1 Day 14 and Cycle 2 Day 1	Concentrations after administration of sunitinib alone (Day 14 of Cycle 1) and those after administration of sunitinib in combination with mFOLFOX6 (Day 1 of Cycle 2) were evaluated.
Best Overall Response Based on Response Evaluation Criteria in Solid Tumors (RECIST)	Up to the last subject completed Cycle 24 or individual study discontinuation	Complete response (CR): 2 or more sequential occasions of documented objective disappearance of all target lesions at a minimum of 4 weeks apart; partial response (PR): 2 or more occasions of \>=30% decrease in the sum of the longest diameter (LD) of the target lesions from baseline at a minimum of 4 weeks apart; stable disease (SD): at least 1 objective status of stable/no response at least 6 weeks after enrollment; progressive disease (PD): Objective status of progression within 12 weeks of enrollment, not qualifying as CR, PR or Stable; Indeterminate: no other response category applies.
Duration of Response (DR)	Up to 733 days (the last subject study discontinuation)	Duration of response is defined as the duration from the date of first documentation of complete response (CR) or partial response (PR) to date of first documentation of objective progression based on the investigator's assessment.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇯🇵 Chuo-ku, Tokyo, Japan