Study With AG-013736 Combined With Chemotherapy And Bevacizumab In Patients With Metastatic Colorectal Cancer

Pfizer

Status and phase: Completed; Phase 2; Phase 1

Conditions: Colorectal Neoplasms

Treatments: Drug: AG-013736 (axitinib); Drug: bevacizumab; Drug: AG-013726

Study type: Interventional

Funder types: Industry

Identifiers

NCT00460603

A4061020

Details and patient eligibility

About

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.

Enrollment: 187 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• (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 criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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187 participants in 3 patient groups

B

Active Comparator group

Description:

bevacizumab 5 mg/kg every 2 weeks + FOLFOX

Treatment:

Drug: bevacizumab

C

Experimental group

Description:

AG-013726 5 mg bid+ bevacizumab 2 mg/kg every 2 weeks + FOLFOX

Treatment:

Drug: AG-013726

A

Experimental group

Description:

AG-013736 5 mg bid starting dose + FOLFOX

Treatment:

Drug: AG-013736 (axitinib)