Study Of Sunitinib With FOLFIRI In Colorectal Cancer

NCT00668863 | Completed Phase 2 Results

• 1 other identifier: A6181151
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 10

Brief Summary

To evaluate the efficacy, safety and pharmacokinetics of sunitinib plus FOLFIRI (irinotecan, 5-FU and l-leucovorin) in the first-line treatment of Japanese mCRC patients

Conditions

Unresectable or Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  PFS is defined as the time from the date of enrollment to the date of the first documentation of objective tumor progression or death due to any cause, whichever occurs first. PFS data was censored on the day following the date of the last tumor assessment documenting absence of progressive disease for patients who 1) were given anti-tumor treatment other than the study treatment prior to observing objective tumor progression; 2) were removed from the study prior to documentation of objective tumor progression; and 3) were ongoing at the time of the analysis.

  Up to 11 cycles (1 cycle = 6 weeks)

Secondary Outcomes (15)

• Overall Survival (OS)

  Up to 11 cycles (1 cycle = 6 weeks)

• Percentage of Participants Who Presented Objective Response: Objective Response Rate (ORR)

  Up to 11 cycles (1 cycle = 6 weeks)

• Duration of Response (DR)

  Up to 11 cycles (1 cycle = 6 weeks)

• Maximum Observed Plasma Concentration (Cmax) and Predose Concentration (Ctrough) of Sunitinib.

  Cycle 1 Day 15

• Time to Reach Maximum Plasma Concentration (Tmax) of Sunitinib

  Cycle 1 Day 15

Study Arms (1)

1

EXPERIMENTAL

Drug: FOLFIRI (The combination regimen of Irinotecan, l-Leucovorin and 5-Fluorouracil); Drug: Sunitinib

Interventions

FOLFIRI (The combination regimen of Irinotecan, l-Leucovorin and 5-Fluorouracil) DRUG

FOLFIRI treatment with Sunitinib on Day, Irinotecan 180M/M IV , l-Leucovorin 200M/M, 5FU 400M/M bolus and 2400M/M in 46-hour continuous infusion on Day1 each 42 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.

1

Sunitinib DRUG

37.5mg daily P.O., 4 weeks On 2weeks Off each 42 day cycle. Number of cycles: until progression or unacceptable toxicity develops.

Also known as: Sutent

1

Eligibility Criteria

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

You may qualify if:

• Patient with histologically- or cytologically-confirmed colorectal adenocarcinoma with unresectable or metastatic disease documented on diagnostic imaging studies.
• Patient must have at least one RECIST-defined measurable lesion that has not been treated with prior local therapy.

You may not qualify if:

• History of another primary malignancy within 3 years prior to study entry, with the exception of non-melanoma skin cancer and in situ carcinoma of the uterine cervix.
• Current, recent, or planned participation in an experimental treatment drug study other than this protocol.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (10)

Pfizer Investigational Site

Nagoya, Aichi-ken, Japan

Location

Pfizer Investigational Site

Chiba, Chiba, Japan

Location

Pfizer Investigational Site

Matsuyama, Ehime, Japan

Location

Pfizer Investigational Site

Sapporo, Hokkaido, Japan

Location

Pfizer Investigational Site

Minoh/Osaka, Japan, Japan

Location

Pfizer Investigational Site

Kochi, Kochi, Japan

Location

Pfizer Investigational Site

Saku, Nagano, Japan

Location

Pfizer Investigational Site

Osakasayama-shi, Osaka, Japan

Location

Pfizer Investigational Site

Takatsuki, Osaka, Japan

Location

Pfizer Investigational Site

Shimotsuke-shi, Tochigi, Japan

Location

Related Publications (1)

• Tsuji Y, Satoh T, Tsuji A, Muro K, Yoshida M, Nishina T, Nagase M, Komatsu Y, Kato T, Miyata Y, Mizutani N, Hashigaki S, Lechuga MJ, Denda T. First-line sunitinib plus FOLFIRI in Japanese patients with unresectable/metastatic colorectal cancer: a phase II study. Cancer Sci. 2012 Aug;103(8):1502-7. doi: 10.1111/j.1349-7006.2012.02320.x. Epub 2012 Jun 14.

  PMID: 22537162 DERIVED

Related Links

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

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Leucovorin; Fluorouracil; 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)

Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Pyrroles; Azoles; Indoles

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 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2008
• First Posted: April 29, 2008
• Study Start: May 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: October 17, 2011
• Results First Posted: October 7, 2011

Record last verified: 2011-10

Locations

JP (10)