Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
SU011248 in Treating Patients With Metastatic Colorectal Adenocarcinoma (Cancer) That Has Not Responded to Previous Treatment With Irinotecan, Oxaliplatin, and a Fluoropyrimidine With or Without Bevacizumab
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00082771
  Purpose

RATIONALE: SU011248 may stop the growth of tumor cells by blocking the enzymes necessary for their growth.

PURPOSE: This phase II trial is studying how well SU011248 works in treating patients with metastatic colorectal adenocarcinoma (cancer) that has not responded to previous treatment with irinotecan, oxaliplatin, and a fluoropyrimidine (such as fluorouracil) with or without bevacizumab.


Condition Intervention Phase
Colorectal Cancer
Drug: sunitinib malate
Phase II

MedlinePlus related topics: Cancer Colorectal Cancer
Drug Information available for: Irinotecan Irinotecan hydrochloride Sunitinib Sunitinib malate Bevacizumab Oxaliplatin Malic acid
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Study Of SU011248 In Patients With Metastatic Colorectal Cancer Who Have Previously Failed Treatment With Irinotecan, Oxaliplatin, And Fluoropyrimidine, With And Without Bevacizumab

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: January 2004
Detailed Description:

OBJECTIVES:

Primary

  • Determine the antitumor efficacy of SU011248 in patients with metastatic colorectal adenocarcinoma who failed prior treatment with irinotecan, oxaliplatin, and a fluoropyrimidine with or without bevacizumab.

Secondary

  • Determine the onset and duration of tumor control and 1-year survival rate in patients treated with this drug.
  • Determine the safety of this drug in these patients.

OUTLINE: This is an open-label, multicenter study. Patients are stratified according to prior bevacizumab (yes vs no).

Patients receive oral SU011248 once daily on days 1-28. Courses repeat every 42 days for up to 1 year in the absence of disease progression or unacceptable toxicity.

Patients are followed at 30 days and then every 2 months for 1 year.

PROJECTED ACCRUAL: A total of 76-126 patients (38-63 per stratum) will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed colorectal adenocarcinoma not amenable to surgery, radiotherapy, or combined modality therapy with curative intent
  • Must have received prior irinotecan, oxaliplatin, and a fluoropyrimidine in the adjuvant and/or advanced disease setting with or without bevacizumab (in the advanced disease setting) AND developed resistance to these prior therapies, as defined by one of the following:

    • Irinotecan-, oxaliplatin-, or fluoropyrimidine-resistant disease, defined as relapse or progression during treatment OR within 6 months after completing the most recent regimen
    • Bevacizumab-resistant disease, defined as disease progression during treatment OR within 6 months after completing bevacizumab
  • At least one unidimensionally measurable lesion at least 20 mm by conventional radiographic techniques or MRI OR at least 10-16 mm by spiral CT scan

    • The following lesions are not considered measurable:

      • Bone lesions
      • Ascites
      • Peritoneal carcinomatosis or miliary lesions
      • Pleural or pericardial effusions
      • Lymphangitis of the skin or lung
      • Cystic lesions
      • Irradiated lesions
      • Disease documented by indirect evidence only (e.g., by laboratory test, such as alkaline phosphatase)
  • No known brain or leptomeningeal disease

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9.0 g/dL

Hepatic

  • AST and ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if abnormalities are due to underlying malignancy)
  • Albumin ≥ 3.0 g/dL
  • Bilirubin ≤ 1.5 times ULN
  • PT and PTT ≤ 1.5 times ULN

Renal

  • Creatinine ≤ 1.5 times ULN

Cardiovascular

  • LVEF above lower limit of normal by MUGA
  • No ongoing cardiac dysrhythmias ≥ grade 2
  • No atrial fibrillation of any grade
  • No prolongation of the QTc interval to > 450 msec (for males) or > 470 msec (for females)
  • None of the following conditions within the past 12 months:

    • Myocardial infarction
    • Severe/unstable angina
    • Symptomatic congestive heart failure
    • Cerebrovascular accident
    • Transient ischemic attack
    • Deep vein thrombosis
    • Other thromboembolic event

Pulmonary

  • No pulmonary embolism within the past 12 months

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Amylase and lipase ≤ ULN
  • Adrenocorticotrophic hormone stimulation test normal
  • No known HIV infection
  • No AIDS-related illness
  • No other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would preclude study participation
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics
  • At least 3 weeks since prior immunotherapy and recovered
  • No prior vascular endothelial growth factor inhibitors (except bevacizumab)
  • No concurrent biological response modifiers
  • No concurrent immunotherapy

Chemotherapy

  • See Disease Characteristics
  • At least 3 weeks since prior chemotherapy
  • No more than 3 prior systemic chemotherapy-based regimens for advanced disease
  • Prior chemoembolization therapy allowed provided areas of measurable disease are not affected
  • No concurrent chemotherapy

Endocrine therapy

  • No concurrent hormonal therapy

Radiotherapy

  • See Disease Characteristics
  • At least 3 weeks since prior radiotherapy and recovered

    • Areas of measurable disease must not be affected
  • No concurrent radiotherapy to the sole site(s) of measurable disease

    • Concurrent palliative radiotherapy allowed provided the measurable lesions (study target lesions) are not included in the irradiated field

Surgery

  • Recovered from prior surgery
  • Prior surgery allowed provided areas of measurable disease are not affected
  • More than 12 months since prior coronary/peripheral artery bypass graft
  • No concurrent surgery in the sole site(s) of measurable disease

Other

  • Prior intrahepatic therapy or cryotherapy allowed provided areas of measurable disease are not affected
  • No prior tyrosine kinase inhibitors (except bevacizumab)
  • No other concurrent anticancer treatment
  • No other concurrent investigational drugs
  • No concurrent participation in another clinical trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00082771

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: Leonard B. Saltz, MD Memorial Sloan-Kettering Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications of Results:
Saltz LB, Rosen LS, Marshall JL, Belt RJ, Hurwitz HI, Eckhardt SG, Bergsland EK, Haller DG, Lockhart AC, Rocha Lima CM, Huang X, DePrimo SE, Chow-Maneval E, Chao RC, Lenz HJ. Phase II trial of sunitinib in patients with metastatic colorectal cancer after failure of standard therapy. J Clin Oncol. 2007 Oct 20;25(30):4793-9.
Lenz H, Marshall J, Rosen L, et al.: Phase II trial of SU11248 in patients with metastatic colorectal cancer (MCRC) after failure of standard chemotherapy. [Abstract] American Society of Clinical Oncology 2006 Gastrointestinal Cancers Symposium, 26-28 January 2006, San Francisco, California. A-241, 2006.

Study ID Numbers: CDR0000360732, MSKCC-03143, PFIZER-A6181003, PFIZER-PHA-RTKC-0511
Study First Received: May 14, 2004
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00082771  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV colon cancer
stage IV rectal cancer
adenocarcinoma of the colon
adenocarcinoma of the rectum
recurrent colon cancer
recurrent rectal cancer

Study placed in the following topic categories:
Digestive System Neoplasms
Rectal Neoplasms
Gastrointestinal Diseases
Irinotecan
Colonic Diseases
Bevacizumab
Intestinal Diseases
Rectal Diseases
Recurrence
Intestinal Neoplasms
Rectal neoplasm
Carcinoma
Oxaliplatin
Digestive System Diseases
Sunitinib
Gastrointestinal Neoplasms
Adenocarcinoma
Rectal cancer
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Antineoplastic Agents
Growth Substances
Therapeutic Uses
Physiological Effects of Drugs
Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009