Status:
COMPLETED
Study With AG-013736 Combined With Chemotherapy And Bevacizumab In Patients With Metastatic Colorectal Cancer
Lead Sponsor:
Pfizer
Conditions:
Colorectal Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
To determine the safety and efficacy of AG-013736 in combination with other standard of care medication in patients with first line metastatic colorectal cancer.
Eligibility Criteria
Inclusion
- (Phase 1) Patients with any solid/GI tumor who have had no more than 1 previous chemotherapy for greater than 3 months prior to enrollment
- (Phase 2) Patients with locally advanced or metastatic colorectal cancer (CRC) previously untreated with any systemic therapy.
- Patients treated with adjuvant chemotherapy (with radiation) will be eligible if last treatment was \> 12 months prior to enrollment,
- Patients must have measurable disease by RECIST and if any history of hypertension, it must be controlled with medication.
Exclusion
- Prior system therapy for advanced CRC (Ph 2 portion only)
- Prior treatment with anti-angiogenesis agent such as bevacizumab or VEGF inhibitors.
- Prior irradiation of greater than 25% of bone marrow (whole pelvis = 25%)
- Prior radiation, major surgery, or investigational agent within 4 weeks of study entry except palliative radiotherapy to non-target, metastatic lesions. Minor surgeries should be completed \> 2 weeks of enrollment and be fully recovered from any procedure.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
187 Patients enrolled
Trial Details
Trial ID
NCT00460603
Start Date
January 1 2006
End Date
November 1 2012
Last Update
December 6 2013
Active Locations (106)
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1
Pfizer Investigational Site
Daphne, Alabama, United States, 36526
2
Pfizer Investigational Site
Huntsville, Alabama, United States, 35801
3
Pfizer Investigational Site
Huntsville, Alabama, United States, 35805
4
Pfizer Investigational Site
Mobile, Alabama, United States, 36608