Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01871571
Study type Interventional
Source University of Southern California
Contact
Status Active, not recruiting
Phase Phase 2
Start date August 2, 2013
Completion date June 24, 2023

See also
  Status Clinical Trial Phase
Terminated NCT01934179 - Telomere Length in Predicting Toxicity in Older Patients With Stage III-IV Colorectal Cancer Undergoing Chemotherapy N/A
Completed NCT01846520 - Family Caregiver Palliative Care Intervention in Supporting Caregivers of Patients With Stage II-IV Gastrointestinal, Gynecologic, Urologic and Lung Cancers N/A
Completed NCT01740648 - Trametinib, Fluorouracil, and Radiation Therapy Before Surgery in Treating Patients With Stage II-III Rectal Cancer Phase 1
Completed NCT00005036 - Irinotecan Compared With Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer Phase 3
Completed NCT01131234 - Gamma-Secretase Inhibitor RO4929097 and Cediranib Maleate in Treating Patients With Advanced Solid Tumors Phase 1
Completed NCT00003799 - Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Locally Advanced Rectal Cancer Phase 1
Completed NCT01643499 - Genotype-guided Dosing of mFOLFIRINOX Chemotherapy in Patients With Previously Untreated Advanced Gastrointestinal Malignancies Phase 1
Withdrawn NCT02287727 - Regorafenib in Reducing Recurrence in Patients With Non-metastatic Rectal Cancer Who Have Completed Curative-Intent Treatment Phase 2
Completed NCT01802320 - Akt Inhibitor MK2206 in Treating Patients With Previously Treated Colon or Rectal Cancer That is Metastatic or Locally Advanced and Cannot Be Removed by Surgery Phase 2
Completed NCT00060411 - A Phase I, Pharmacological, and Biological Study of OSI-774 in Combination With FOLFOX 4 (5-FU, Leucovorin, and Oxaliplatin) and Bevacizumab (Avastin) in Patients With Advanced Colorectal Cancer Phase 1
Completed NCT02132858 - Genetic Mutations in Blood and Tissue Samples in Predicting Response to Treatment in Patients With Locally Advanced Rectal Cancer Undergoing Chemoradiation
Completed NCT00754494 - Erlotinib Hydrochloride in Treating Patients With Stage I-III Colorectal Cancer or Adenoma Phase 2
Completed NCT02232152 - CPI-613 and Fluorouracil in Treating Patients With Metastatic Colorectal Cancer That Cannot Be Removed by Surgery Phase 1
Completed NCT01726296 - Adherence to Survivorship Care Guidelines in Health Care Providers for Non-Small Cell Lung Cancer and Colorectal Cancer Survivor Care N/A
Completed NCT01741636 - Survivorship Care Planning in Patients With Colorectal or Non-Small Cell Lung Cancer N/A
Completed NCT00103311 - SB-715992 in Treating Patients With Advanced or Metastatic Colorectal Cancer Phase 2
Completed NCT02270606 - Phase I Study of Neoadjuvant Radiotherapy With 5-Fluorouracil for Rectal Cancer Phase 1
Active, not recruiting NCT03154190 - Health Care Coach Support in Reducing Acute Care Use and Cost in Patients With Cancer N/A
Terminated NCT04044430 - Encorafenib, Binimetinib, and Nivolumab in Treating Microsatellite Stable BRAF V600E Metastatic Colorectal Cancer Phase 1
Completed NCT02148406 - Programs to Support You During Chemotherapy (Pro-You) N/A