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Completed

NCT Number: NCT00631410

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

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.

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Key information

Conditions

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

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site, Kashiwa, Chiba, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

sunitinib + mFOLFOX6

Drug

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

Primary outcomes

  1. Number of Participants With Adverse Events

    Time frame: 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 outcomes

  1. Plasma Concentration of Sunitinib

    Time frame: 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.

  2. Plasma Concentration of Sunitinib Active Metabolite (SU012662)

    Time frame: 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.

  3. Plasma Concentration of the Total Drug (Sunitinib Plus SU012662)

    Time frame: 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.

  4. 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

    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.

  5. Duration of Response (DR)

    Time frame: 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.

  6. Progression-Free Survival (PFS)

    Time frame: 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.

  7. 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)

    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.

  8. 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)

    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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Phase I Study Of Sunitinib In Combination With Oxaliplatin, L-Leucovorin, And 5-Fluorouracil In Patients With Metastatic Colorectal Cancer

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Mar 7, 2008
Registry last updated
Mar 16, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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