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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00631410
First received: January 2, 2008
Last updated: March 11, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Colorectal Neoplasms
Drug: sunitinib + mFOLFOX6
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study Of Sunitinib In Combination With Oxaliplatin, L-Leucovorin, And 5-Fluorouracil In Patients With Metastatic Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants With Adverse Events [ Time Frame: Up to 733 days (the last subject study discontinuation) ] [ Designated as safety issue: Yes ]
    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:
  • Plasma Concentration of Sunitinib [ Time Frame: Cycle 1 Day 14 and Cycle 2 Day 1 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Cycle 1 Day 14 and Cycle 2 Day 1 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Cycle 1 Day 14 and Cycle 2 Day 1 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Up to the last subject completed Cycle 24 or individual study discontinuation ] [ Designated as safety issue: No ]
    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) [ Time Frame: Up to 733 days (the last subject study discontinuation) ] [ Designated as safety issue: No ]
    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.

  • Progression-Free Survival (PFS) [ Time Frame: Up to 733 days (the last subject study discontinuation) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 733 days (the last subject study discontinuation in the Treatment Arm A) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 384 days (the last subject study discontinuation in the Treatment Arm B) ] [ Designated as safety issue: No ]
    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.


Enrollment: 12
Study Start Date: January 2008
Study Completion Date: March 2010
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: sunitinib + mFOLFOX6
37.5 mg/day, oral, administered on an outpatient basis for 4 weeks on, 2 weeks off (Schedule 4/2)
Experimental: B Drug: sunitinib + mFOLFOX6
50 mg/day, oral, administered on an outpatient basis for 2 weeks on, 2 weeks off (Schedule 2/2)

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00631410

Locations
Japan
Pfizer Investigational Site
Kashiwa, Chiba, Japan
Pfizer Investigational Site
Suntougun, Shizuoka, Japan
Pfizer Investigational Site
Chuo-ku, Tokyo, Japan
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00631410     History of Changes
Other Study ID Numbers: A6181148
Study First Received: January 2, 2008
Results First Received: July 21, 2010
Last Updated: March 11, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Pfizer:
Phase 1
CRC
SU011248
Sunitinib
FOLFOX
Colorectal cancer
metastatic carcinoma of the colon or rectum

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Sunitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on July 22, 2014