A Study of Bevacizumab (Avastin) in Participants With Newly Diagnosed Locally Advanced Rectal Cancer (INOVA)

Roche

Status and phase: Completed; Phase 2

Conditions: Rectal Cancer

Treatments: Drug: 5-fluorouracil; Drug: Oxaliplatin; Drug: Bevacizumab; Drug: Folinic Acid; Procedure: Surgery; Radiation: Preoperative Radiotherapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT00865189

2006-003472-35 (EudraCT Number)

ML19202

Details and patient eligibility

About

This study will assess the efficacy and safety of two different neoadjuvant treatment approaches including bevacizumab in newly diagnosed participants with high risk locally advanced rectal cancer. Participants will be randomized into one of two treatment arms (Arm A or Arm B).

Enrollment: 91 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• histologically confirmed locally advanced rectal cancer;
• measurable disease;
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

Exclusion criteria

• prior treatment with bevacizumab;
• prior radiotherapy to pelvic region, or previous cytotoxic chemotherapy;
• previous history of malignancy (other than basal and squamous cell cancer of the skin, or in situ cancer of the cervix);
• history or evidence of central nervous system (CNS) disease;
• clinically significant cardiovascular disease;
• chronic treatment with high dose aspirin (more than [>] 325 milligrams per day [mg/day]) or non-steroidal anti-inflammatory drugs.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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91 participants in 2 patient groups

Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy)

Experimental group

Description:

In this arm, participants will undergo 3 phases of treatment. During the Phase 1, participants will receive induction chemotherapy with 6 two-week cycles of bevacizumab + Folfox-4 (5-FU + oxaliplatin + folinic acid) for 12 weeks followed by a treatment-free interval of 3 to 4 weeks. The Phase 2 will include 7 weeks of bevacizumab + chemoradiotherapy (intravenous \[IV\] infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy \[5-FU + radiotherapy\], with administration of bevacizumab every two weeks \[Cycles 1, 3 and 5\]) followed by a treatment-free interval of 6 to 8 weeks. The Phase 3 will be surgery involving a radical rectal excision using the total mesorectal excision (TME) technique.

Treatment:

Drug: 5-fluorouracil

Drug: Bevacizumab

Drug: Oxaliplatin

Drug: Folinic Acid

Radiation: Preoperative Radiotherapy

Procedure: Surgery

Arm B (Bevacizumab, Chemoradiotherapy)

Experimental group

Description:

In this arm, participants will receive the Phase 2 and Phase 3 treatments only. The phase 2 will include 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy \[5-FU + radiotherapy\], with administration of bevacizumab every two weeks \[Cycles 1, 3 and 5\]) followed by a treatment-free interval of 6 to 8 weeks. The phase 3 will be surgery involving a radical rectal excision using the TME technique.

Treatment:

Drug: 5-fluorouracil

Drug: Bevacizumab

Radiation: Preoperative Radiotherapy

Procedure: Surgery