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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00936832
Recruitment Status : Withdrawn (because the sunitinib showed futility in anotehr trial)
First Posted : July 10, 2009
Last Update Posted : March 4, 2014
Information provided by (Responsible Party):
Federation Francophone de Cancerologie Digestive

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Metastatic Cancer Drug: FOLFIRI regimen Drug: fluorouracil Drug: irinotecan hydrochloride Drug: leucovorin calcium Drug: sunitinib malate Other: laboratory biomarker analysis Other: pharmacogenomic studies Other: pharmacological study Phase 2

Detailed Description:



  • Evaluation of the efficacy of front-line treatment with sunitinib malate and FOLFIRI chemotherapy at 3 months in patients with rectal cancer and synchronous metastases deemed unresectable in a multidisciplinary consultation.


  • Evaluate the rate of resection of secondary metastases and rectal cancer, rate of R0 resection of metastases and rectal cancer, and the rate of complete response after resection.
  • Evaluate the rate of local failure (progression of rectal cancer).
  • Evaluate the rate of local complications.
  • Evaluate disease-free survival.
  • Evaluate progression-free survival, metastatic progression-free survival, and local progression-free survival.
  • Evaluate symptom-free survival.
  • Evaluate overall survival.
  • Evaluate quality of life, specifically fatigue and global health score (EORTC QLQ-C30).
  • Evaluate the tolerance to treatment.
  • Conduct translational research, in particular, pharmacokinetic studies of plasma and rectal tumor biopsies, and histological and molecular studies.

OUTLINE: Patients receive simplified FOLFIRI chemotherapy comprising irinotecan hydrochloride IV over 90 minutes, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on days 1, 15, and 29. Patients also receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.

Patients may undergo surgical resection and/or local radiotherapy if the tumor regresses. After resection or radiotherapy, patients may undergo up to 4 more courses of study treatment.

Biopsies of the tumor and healthy mucosa are collected for translational research at baseline. Blood samples are collected for pharmacodynamic and pharmacogenetic studies at baseline and at week 6. Patients also complete a quality-of-life questionnaire (EORTC QLQ-C30) at baseline and periodically thereafter.

After completion of study therapy, patients are followed up every 12 weeks.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Front-line Combination Therapy of Sunitinib Malate Plus Chemotherapy With Leucovorin/5-Fluorouracil and Irinotecan (FOLFIRI) for Rectal Cancer Patients With Synchronous Non-Resectable Metastases: A Phase II Non Controlled Study. (SUREMETS)
Study Start Date : April 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Response rate at 3 months as assessed by RECIST criteria

Secondary Outcome Measures :
  1. Rate of complete response after resection
  2. Rate of R0 resection of metastases
  3. Rate of local failure
  4. Rate of local complications
  5. Metastatic progression-free survival
  6. Local progression-free survival
  7. Disease-free survival
  8. Symptom-free survival
  9. Overall survival
  10. Quality of life, specifically fatigue and global health score (EORTC QLQ-C30)
  11. Time to deterioration of the final score for overall health and fatigue
  12. Tolerance and incidence of side effects as assessed by NCI CTCAE v2
  13. Translational research including pharmacodynamic studies of plasma and rectal tumor biopsies and histological and molecular studies

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00936832

Hopital Ambroise Pare
Boulogne Billancourt, France, 92100
Sponsors and Collaborators
Federation Francophone de Cancerologie Digestive
Principal Investigator: Philippe Rougier, MD Hopital Ambroise Pare

Responsible Party: Federation Francophone de Cancerologie Digestive Identifier: NCT00936832     History of Changes
Other Study ID Numbers: CDR0000637832
First Posted: July 10, 2009    Key Record Dates
Last Update Posted: March 4, 2014
Last Verified: July 2009

Keywords provided by Federation Francophone de Cancerologie Digestive:
stage IV rectal cancer
adenocarcinoma of the rectum
liver metastases
lung metastases

Additional relevant MeSH terms:
Colorectal Neoplasms
Rectal Neoplasms
Neoplasm Metastasis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs