Sunitinib Malate and Combination Chemotherapy as Front-Line Therapy in Treating Patients With Metastatic Rectal Cancer That Cannot Be Removed by Surgery

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as irinotecan hydrochloride, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) together with sunitinib malate may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving sunitinib malate together with combination chemotherapy works as front-line therapy in treating patients with metastatic rectal cancer that cannot be removed by surgery.

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

Details

• Lead Sponsor: Federation Francophone de Cancerologie Digestive
• Treatments: Calcium; Fluorouracil; Irinotecan; Leucovorin; Levoleucovorin; Sunitinib

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the rectum

• Lower pole of the tumor < 12 cm from the anal margin

• Synchronous metastases of the liver and/or lung

• Unresectable or resectability uncertain according to the decision of a local multidisciplinary consultation

• Lesions measurable in 1 dimension by RECIST criteria (metastases and primary rectal cancer)

• No rectal obstruction requiring surgery or the emergency fitting of a prosthesis

• No CNS metastases

PATIENT CHARACTERISTICS:

• WHO performance status 0-2

• ANC ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

• Creatinine clearance ≥ 60 mL/min

• Hemoglobin ≥ 10 g/dL (transfusions allowed)

• FEV ≥ 50%

• QT interval ≤ 450 ms (in men) or ≤ 470 ms (in women)

• Total bilirubin ≤ 1.5 times upper limit of normal

• Serum albumin ≥ 25 g/L

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No history of another cancer except for nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix

• History of other cancers allowed provided the patient has been disease-free > 3 years

• None of the following:

• Congestive heart failure or coronary heart disease

• Myocardial infarction within the past year

• Uncontrolled hypertension (systolic BP > 160 mm Hg or diastolic BP > 100 mm Hg) despite optimal medical management

• No active severe rectal bleeding

• No liver failure

• No known Gilbert syndrome

• No severe uncontrolled infection

• No chronic diarrhea, malabsorption syndrome, or intestinal obstruction/subocclusion

• No severe uncontrolled pain (visual analogue scale 5/10) with morphine treatment

• No other medical, psychological, or social condition that, in the investigator's opinion, could affect the patient's compliance with study treatment

• No hypersensitivity to any component of study treatment

PRIOR CONCURRENT THERAPY:

• See Patient Characteristics

• No prior radiotherapy to the pelvis

• More than 4 weeks since prior experimental therapy

• More than 7 days since prior CYP3A4 inhibitor before the administration of sunitinib malate

• More than 12 days since prior CYP3A4 inducer

• No concurrent participation in another clinical study

• No other concurrent anticancer therapy