Study Of Sunitinib In Combination With Folfox In Patients With Colorectal Cancer
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00631410
First received: January 2, 2008
Last updated: March 11, 2011
Last verified: March 2011
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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
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 May 23, 2013