Know Cancer

or
forgot password

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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Metastatic Colorectal Cancer

Thank you

Trial Information

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


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


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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease-free survival

Outcome Description:

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

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Emmanuelle Samalin-Scalzi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Val d'Aurelle Cancer Institute

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

BEVATOMOX

NCT ID:

NCT01532804

Start Date:

July 2011

Completion Date:

December 2014

Related Keywords:

  • Metastatic Colorectal Cancer
  • Unresectable metastases
  • Colorectal Neoplasms

Name

Location