Study Of Sunitinib Plus FOLFOX In Patients With Solid Tumors

NCT00599924 | Completed Phase 1 Results

• 1 other identifier: A6181048
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 3

Brief Summary

This study determined the maximum tolerated dose and safety of SU011248 (sunitinib malate, SUTENT) in combination with FOLFOX \[Leucovorin + Fluorouracil (5-FU) + Oxaliplatin\]. Three different dosing regimens with starting doses of sunitinib at 37.5 mg/day (Schedule 2/2, Schedule 4/2, and Continuous Dosing) were tested in patients with advanced solid tumors, including colorectal cancer.

Conditions

Colorectal Neoplasms; Neoplasms

Keywords

advanced solid tumors,; colorectal cancer,; sunitinib (SUTENT),; FOLFOX

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product(s) were reported.

  up to 20 weeks

Secondary Outcomes (29)

• Objective Response (OR)

  From start of treatment until Day 8 of Cycles 4 and 8 (2/2 Schedule), Day 8 of Cycles 3 and 6 (4/2 Schedule), and Day 1 of Cycles 3 and 7 (Continuous Dosing)

• Maximum Plasma Concentration (Cmax) of Sunitinib

  pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose

• Time to Cmax (Tmax) of Sunitinib

  pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose

• Minimum Plasma Concentration (Cmin) of Sunitinib

  pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose

• Clearance (CL/F) of Sunitinib

  pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose

Study Arms (1)

Single arm

EXPERIMENTAL

SU011248 \[sunitinib\] in combination with FOLFOX; FOLFOX is a chemotherapy regimen that combines oxaliplatin and leucovorin with bolus and infusion 5-FU. The modified FOLFOX 6 (mFOLFOX6) regimen is one of several different regimens of FOLFOX used in clinic, according to different dosages of the 4 drugs. mFOLFOX6 was administered every 2 weeks on Days 1 and 2 of each cycle. 25, 37.5 and 50 mg/day, oral, administered on an outpatient basis in three different dosing regimens: schedule 2/2 (2 weeks on, 2 weeks off), schedule 4/2 (4 weeks on, 2 weeks off), and continuous daily dosing (every day); FOLFOX will be administered every 2 weeks, using the modified FOLFOX 6 (mFOLFOX6) regimen, consisting of: oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 as a 2-hr IV infusion; 5-FU 400 mg/m2 IV bolus, followed by - 5-FU 2400 mg/m2 as a 46-hr IV infusion

Drug: sunitinib + FOLFOX

Interventions

sunitinib + FOLFOX DRUG

37.5 mg sunitinib + modified FOLFOX6 (Schedule 2/2)

Also known as: Sunitinib malate, SUTENT, mFOLFOX6

Single arm

Eligibility Criteria

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

You may qualify if:

• Advanced solid tumor malignancy (during expansion at the maximum tolerated dose, entry will be limited to patients wtih adenocarcinoma of the colon or rectum)
• Eastern Cooperative Oncology Group (ECOG) 0 or 1

You may not qualify if:

• Prior treatment with more than 6 cycles of traditional alkylating agent-based chemotherapy regimens
• Prior treatment with more than 2 cycles of carboplating-based chemotherapy regimens
• For colorectal cancer patients in the expanded cohorts, prior treatment with more than 2 systemic chemotherapy regimens in the metastatic setting

Sponsors & Collaborators

• Pfizer: lead

Study Sites (3)

Pfizer Investigational Site

Aurora, Colorado, 80045, United States

Location

Pfizer Investigational Site

Nashville, Tennessee, 37232, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75246, United States

Location

Related Links

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

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasms

Interventions

Sunitinib; Folfox protocol

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; 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.govCallCenter@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: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2008
• First Posted: January 24, 2008
• Study Start: September 1, 2005
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: July 15, 2015
• Results First Posted: December 9, 2009

Record last verified: 2015-06

Locations

US (3)