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

NCT00936832 | Withdrawn Phase 2

• 4 other identifiers: CDR0000637832FFCD-0801EUDRACT-2008-005959-19EU-20918
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colorectal Cancer; Metastatic Cancer

Keywords

stage IV rectal cancer; adenocarcinoma of the rectum; liver metastases; lung metastases

Outcome Measures

Primary Outcomes (1)

• Response rate at 3 months as assessed by RECIST criteria

Secondary Outcomes (13)

• Rate of complete response after resection

• Rate of R0 resection of metastases

• Rate of local failure

• Rate of local complications

• Metastatic progression-free survival

Interventions

FOLFIRI regimen DRUG

fluorouracil DRUG

irinotecan hydrochloride DRUG

leucovorin calcium DRUG

sunitinib malate DRUG

laboratory biomarker analysis OTHER

pharmacogenomic studies OTHER

pharmacological study OTHER

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Federation Francophone de Cancerologie Digestive: lead

Study Sites (1)

Hopital Ambroise Pare

Boulogne-Billancourt, 92100, France

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis; Rectal Neoplasms

Interventions

Fluorouracil; Irinotecan; Leucovorin; Sunitinib; Pharmacogenomic Testing

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; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Camptothecin; Alkaloids; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Pyrroles; Azoles; Indoles; Genetic Testing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Study Officials

• Philippe Rougier, MD

  Hopital Ambroise Pare

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 8, 2009
• First Posted: July 10, 2009
• Study Start: April 1, 2009
• Primary Completion: March 24, 2010
• Study Completion: March 24, 2010
• Last Updated: August 30, 2022

Record last verified: 2009-07

Locations

FR (1)