2nd-line Treatment of Metastatic Colorectal Cancer

• Status: Terminated
• Trial end date: 2019-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
• Treatments: Bevacizumab; Oxaliplatin; Raltitrexed

Criteria

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)