Study Of Sunitinib In Combination With Folfox In Patients With Colorectal Cancer
NCT00631410
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- 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.
- 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.
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Descriptive Information | ||||
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Brief Title ICMJE | Study Of Sunitinib In Combination With Folfox In Patients With Colorectal Cancer | |||
Official Title ICMJE | Phase I Study Of Sunitinib In Combination With Oxaliplatin, L-Leucovorin, And 5-Fluorouracil In Patients With Metastatic Colorectal Cancer | |||
Brief Summary | 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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Colorectal Neoplasms | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 12 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | March 2010 | |||
Actual Primary Completion Date | July 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
| |||
Ages ICMJE | 20 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Japan | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00631410 | |||
Other Study ID Numbers ICMJE | A6181148 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer Inc | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | March 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |