NCT01871571

Bevacizumab, Fluorouracil, Leucovorin Calcium, and Oxaliplatin Before Surgery in Treating Patients With Stage II-III Rectal Cancer

Phase II Trial Of Neoadjuvant Bevacizumab With Modified FOLFOX7 In Patients With Stage II And III Rectal Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well bevacizumab, fluorouracil, leucovorin calcium, and oxaliplatin before surgery works in treating patients with stage II-III rectal cancer. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as fluorouracil, leucovorin calcium, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with fluorouracil, leucovorin calcium, and oxaliplatin may be an effective treatment for rectal cancer.

Detailed description

PRIMARY OBJECTIVES: I. To determine if six cycles of modified fluorouracil, leucovorin calcium, and oxaliplatin (mFOLFOX7) plus bevacizumab (Avastin) will yield complete pathologic response (cPR) of 25% or more in the primary tumor of patients with stage II and III rectal cancer. SECONDARY OBJECTIVES: I. To assess the rate of tumor regression (pathologic stage lower than clinical stage) after 6 cycles of mFOLFOX7 and bevacizumab in the primary rectal cancer. II. To assess local recurrence rate over 3 years after 6 cycles of mFOLFOX7 and bevacizumab. TERTIARY OBJECTIVES: I. Correlation of the following marker with response (defined as CPR or down staging): * Intratumoral Gene expression and germline polymorphism of genes involved in the vascular endothelial growth factor (VEGF) and VEGF independent pathways (VEGF, vascular endothelial growth factor receptor 1 \[VEGFR1\], VEGFR2, interleukin-8 \[IL8\], chemokine (C-X-C motif) receptor 2 \[CXCR2\], intercellular adhesion molecule \[ICAM\], VEGFR1 and VEGFR2, neuropilin 1 or 2 \[NRP1,2\], cluster of differentiation \[CD\] 44, aldehyde dehydrogenase \[ALDH\], leucine-rich repeats and immunoglobulin-like \[LRIG\]. * Circulating tumor cells (CTC) and VEGF-factor A (A) on the CTC. II. Prediction of surgical resection margin by pretreatment magnetic resonance imaging (MRI). OUTLINE: Patients receive bevacizumab intravenously (IV) over 30-90 minutes, oxaliplatin IV over 2 hours, leucovorin calcium IV, and fluorouracil IV continuously over 46-48 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity. Within 6-8 weeks after treatment, patients undergo surgery. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Conditions

• Mucinous Adenocarcinoma of the Rectum
• Signet Ring Adenocarcinoma of the Rectum
• Stage IIA Rectal Cancer
• Stage IIB Rectal Cancer
• Stage IIC Rectal Cancer
• Stage IIIA Rectal Cancer
• Stage IIIB Rectal Cancer
• Stage IIIC Rectal Cancer

Interventions

Type	Name	Description
BIOLOGICAL	bevacizumab	Given IV
DRUG	oxaliplatin	Given IV
DRUG	leucovorin calcium	Given IV
DRUG	fluorouracil	Given IV
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2013-08-02
• Primary completion: 2022-06-24
• Completion: 2023-06-24
• First posted: 2013-06-06
• Last updated: 2022-08-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study