2nd-line Treatment of Metastatic Colorectal Cancer

Metastatic Colorectal Cancer Clinical Trial

— BEVATOMOX  

Official title:

A Multicenter Randomized Phase 2 Trial to Evaluate the Triplet Combination of Raltitrexed, Oxaliplatin and Bevacizumab Versus FOLFOX6 Plus Bevacizumab in Second-line Treatment of Metastatic Colorectal Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01532804
• Other study ID #: BEVATOMOX
• Secondary ID: 2010-023447-15
• Status: Terminated
• Phase: Phase 2
• Start date: July 28, 2011
• Est. completion date: January 2019

Study information

• Verified date: December 2019
• Source: Institut du Cancer de Montpellier - Val d'Aurelle
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Eligible patients are randomly allocated to receive either bevacizumab with raltitrexed and oxaliplatin combination or bevacizumab with FOLFOX 6 combination. Random allocation schedule is performed using a minimization technique for the following stratification factors:

• Center

• Number of metastatic sites: 1 versus > 1

• Bevacizumab-based first-line therapy: Yes versus No

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 83
• Est. completion date: January 2019
• Est. primary completion date: May 12, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

• Male or female using an effective contraceptive method

• Absence of known or symptomatic brain metastases

• Life expectancy > 3 months

• Informed consent signed prior any study specific procedures

Exclusion Criteria:

• 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

• Psychological, social, geographical disorders or any other condition that would preclude study compliance (treatment administration and study follow-up)

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Drug:
• bevacizumab, oxaliplatin and 5FU combination
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)
• Bevacizumab, oxaliplatin and raltitrexed combination
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

Locations

Country	Name	City	State
France	Val d'Aurelle Cancer Institute	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
Institut du Cancer de Montpellier - Val d'Aurelle

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival	DFS is estimated from the date of randomization until the first date of objectively documented event or death	6 months
Secondary	Treatment-related toxicity	Treatment-related toxicity is evaluated according to the NCI-CTCAE v.4 criteria.	6 months
Secondary	Objective response rate	Objective response rate is evaluated according to the RECIST V 1.1 criteria.	Every 9 weeks
Secondary	Overall survival	OS is estimated from the date of randomization until the date of death from any cause	unk
Secondary	Cost-effectiveness study	The cost-effectiveness study includes the number of hospital stays (treatment and toxicity), the global cost of treatments, and the cost of hospital stays due to treatment-induced toxicity	6 months
Secondary	Quality of life by using the quality of life questionnaire score	Quality of life is measured using the QLQ-C30 questionnaire	6 months