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

NCT00631410 | Completed Phase 1 Results DMC

• 1 other identifier: A6181148
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 3

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.

Conditions

Colorectal Neoplasms

Keywords

Phase 1; CRC; SU011248; Sunitinib; FOLFOX; Colorectal cancer; metastatic carcinoma of the colon or rectum

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events

  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.

  Up to 733 days (the last subject study discontinuation)

Secondary Outcomes (8)

• Plasma Concentration of Sunitinib

  Cycle 1 Day 14 and Cycle 2 Day 1

• Plasma Concentration of Sunitinib Active Metabolite (SU012662)

  Cycle 1 Day 14 and Cycle 2 Day 1

• Plasma Concentration of the Total Drug (Sunitinib Plus SU012662)

  Cycle 1 Day 14 and Cycle 2 Day 1

• Best Overall Response Based on Response Evaluation Criteria in Solid Tumors (RECIST)

  Up to the last subject completed Cycle 24 or individual study discontinuation

• Duration of Response (DR)

  Up to 733 days (the last subject study discontinuation)

Study Arms (2)

A

EXPERIMENTAL

Drug: sunitinib + mFOLFOX6

B

EXPERIMENTAL

Drug: sunitinib + mFOLFOX6

Interventions

sunitinib + mFOLFOX6 DRUG

37.5 mg/day, oral, administered on an outpatient basis for 4 weeks on, 2 weeks off (Schedule 4/2)

A

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (3)

Pfizer Investigational Site

Kashiwa, Chiba, Japan

Location

Pfizer Investigational Site

Suntougun, Shizuoka, Japan

Location

Pfizer Investigational Site

Chuo-ku, Tokyo, Japan

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 2, 2008
• First Posted: March 7, 2008
• Study Start: January 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: March 1, 2010
• Last Updated: March 16, 2011
• Results First Posted: August 17, 2010

Record last verified: 2011-03

Locations

JP (3)