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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Leonard B. Saltz, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000360732

NCT ID:

NCT00082771

Start Date:

January 2004

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • stage IV colon cancer
  • stage IV rectal cancer
  • adenocarcinoma of the colon
  • adenocarcinoma of the rectum
  • recurrent colon cancer
  • recurrent rectal cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Colorectal Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021