2nd-line Treatment of Metastatic Colorectal Cancer

NCT01532804 | Terminated Phase 2 DMC

• 2 other identifiers: BEVATOMOX2010-023447-15
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

This phase 2 trial aims to evaluate the continued use of bevacizumab with raltitrexed and oxaliplatin combination versus FOLFOX6 plus bevacizumab in patients with metastatic colorectal cancer whose disease has progressed after irinotecan-based chemotherapy.

Conditions

Metastatic Colorectal Cancer

Keywords

Unresectable metastases

Outcome Measures

Primary Outcomes (1)

• Disease-free survival

  DFS is estimated from the date of randomization until the first date of objectively documented event or death

  6 months

Secondary Outcomes (5)

• Treatment-related toxicity

  6 months

• Objective response rate

  Every 9 weeks

• Overall survival

  unk

• Cost-effectiveness study

  6 months

• Quality of life by using the quality of life questionnaire score

  6 months

Study Arms (2)

Arm A

EXPERIMENTAL

FOLFOX6 + bevacizumab (D1=D15, 12 cycles)

Drug: bevacizumab, oxaliplatin and 5FU combination

Arm B

EXPERIMENTAL

Raltitrexed + Oxaliplatin + Bevacizumab (D1=D21, 8 cycles)

Drug: Bevacizumab, oxaliplatin and raltitrexed combination

Interventions

bevacizumab, oxaliplatin and 5FU combination DRUG

Bevacizumab 5 mg/kg administered as an iv infusion for 1h30, then for 1h and for 30 min. at the following cycles, respectively. Oxaliplatin 85 mg/m² administered as an iv infusion for 2h Elvorine 200 mg/m² administered as an iv infusion for 2h 5FU 400 mg/m2 bolus then 5FU 2,400 mg/m² iv infusion for 46h D1=D15 (12 cycles)

Arm A

Bevacizumab, oxaliplatin and raltitrexed combination DRUG

Bevacizumab 7.5 mg/kg administered as an iv infusion for 1h30, then administered for 1h and 30 min at the following cycles, respectively. Oxaliplatin 130 mg/m² administered as an iv infusion for 2h Raltitrexed 3 mg/m² administered as an iv infusion for 15 min

Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven colorectal cancer
• Resected or asymptomatic primary tumor
• Metastatic colorectal cancer not eligible for curative surgery
• No major surgery within four weeks of the start of study treatment
• At least one target lesion unidimensionally measurable on cross-sectional imaging according to RECIST criteria (v1.1)
• Disease progression after failure of irinotecan-based chemotherapy
• Bone metastases are allowed if there is at least one other measurable metastatic site
• CT scan of the abdomen, chest and pelvis within 3 weeks of the start of study treatment
• WHO PS ≤ 2
• Platelet count \>= 100,000 mm3
• Hemoglobin \> 10g/dl
• Bilirubin \< 1.5 ULN, AST/ALT \< 5 ULN
• Serum creatinine \< 1.5 ULN, creatinine clearance \> 60 ml/min (Cockcroft)
• A time period of 4 weeks should be respected between the end of previous treatments and study enrollment
• Negative pregnancy test in women of childbearing potential

You may not qualify if:

• Prior raltitrexed-based chemotherapy
• Prior oxaliplatin-based chemotherapy (except for adjuvant treatment completed for more than 6 months)
• Uncontrolled arterial hypertension defined as systolic pressure \> 150 mm Hg or diastolic pressure \> 100 mm Hg
• Malignant hypertension or hypertensive encephalopathy
• Myocardial infarction, pulmonary embolism, or severe vascular disease within 6 months prior to study entry
• Hemorrhagic diathesis or significant pathology of coagulation
• Peripheral neuropathy grade\>2 (NCI-CTC v4.0)
• Hemoptysis \< 1 month
• Venous access device (PAC) or any other minor surgery such as a biopsy within the last 7 days
• Symptomatic brain metastases or carcinomatous meningitis
• History or presence of other cancer within the past 5 years (except curatively treated nonmelanoma skin cancer and in situ cervical cancer)
• Severe bacterial or fungal infection (Grade \> 2 NCI-CTCAE v.4.0)
• Known or suspected sensitivity to one of the study drugs
• Pregnant or breastfeeding women
• Previous enrollment in an investigational drug study within the last 4 weeks

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (1)

Val d'Aurelle Cancer Institute

Montpellier, 34298, France

Location

Related Publications (1)

• Samalin E, Senellart H, Thezenas S, Jacquot S, Ellis S, Akouz FK, Fiess C, Ramdani M, Portales F, Assenat E, Ychou M, Mineur L, Mazard T. The BEVATOMOX phase II trial: raltitrexed/oxaliplatin/bevacizumab vs mFOLFOX6/bevacizumab in 2nd-line metastatic colorectal cancer. Oncologist. 2026 Jan 14:oyag006. doi: 10.1093/oncolo/oyag006. Online ahead of print.

  PMID: 41537257 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Bevacizumab; Oxaliplatin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals

Study Officials

• Emmanuelle Samalin-Scalzi, MD

  Val d'Aurelle Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2012
• First Posted: February 15, 2012
• Study Start: July 28, 2011
• Primary Completion: May 12, 2016
• Study Completion: January 1, 2019
• Last Updated: December 26, 2019

Record last verified: 2019-12

Locations

FR (1)