SU5416 and Irinotecan in Treating Patients With Advanced Colorectal Cancer

Completed · Phase 1/Phase 2

Conditions studied: Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum, Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage III Colon Cancer, Stage III Rectal Cancer, Stage IV Colon Cancer, Stage IV Rectal Cancer

In brief

Phase I/II trial to study the effectiveness of combining SU5416 and irinotecan in treating patients who have advanced colorectal cancer. SU5416 may stop the growth of colorectal cancer by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die

Key facts

Study ID: NCT00005818
Run by: National Cancer Institute (NCI)
People needed: 68
Starts: 2000-03-01
Last updated by the study team: 2013-01-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients must have histologically confirmed adenocarcinoma of the colon or rectum
Patients must have locally advanced or metastatic disease not amendable to potentially curative treatment
Patients must have an ECOG performance status of 0-2
Men and women of any racial and ethnic group
Absolute neutrophil count (neutrophils + bands) of >= 1,500/ul
Platelet count of >= 100,000/ul
Patients must have a serum creatinine of =< 1.5 mg/dL or a calculated creatinine clearance >= 60 mL/min
Serum bilirubin =< 1.5 mg/dL, regardless of whether patients have liver involvement secondary to tumor
SGOT must be =< 3 times institutional upper limit of normal
Patients must be fully recovered from any previous surgery (at least 4 weeks from major surgery)
Patients must have recovered from prior radiation therapy (at least 4 weeks from radiation)
Fertile patients (male and female) must agree to use a medically effective contraceptive method throughout the treatment period and for 3 months following cessation of treatment
Patients must provide written informed consent
Patients must have either measurable or evaluable disease; measurable disease is defined as at least one bidimensionally measurable lesion >= 1 x 1 cm that is outside the field of any prior radiation therapy
In Phase I: Patients with a history of a prior malignancy are eligible for treatment
In Phase II: Patients who have undergone potentially curative therapy for a prior malignancy and who have had no evidence of that disease for > 5 years are eligible for treatment; adequately treated basal cell or squamous cell skin cancer does not apply
In the Phase I portion of the study the following eligibility criteria must be met:
Patients must have received no more than two prior chemotherapy regimens (one of which must have contained a fluorinated pyrimidine) for locally advanced or metastatic disease; if a patient progressed while on or within 6 months of adjuvant therapy, the adjuvant regimen will be considered as treatment for metastatic disease
In the Phase II portion of the study the following eligibility criteria must be met:
Patients must have received one and only one prior chemotherapy regimen, which must have contained a fluorinated pyrimidine, for treatment of locally advanced or metastatic disease; if a patient progressed while on or within 6 months of adjuvant therapy, the adjuvant regimen will be considered as treatment for metastatic disease

You may not qualify if…

Patients who have previously received SU5416, CPT-11, or any topoisomerase I inhibitor
Patients with uncompensated coronary artery disease on electrocardiogram or physical examination, or with a history of myocardial infarction, or severe/unstable angina in the past 6 months are not eligible
Patients with diabetes mellitus with severe peripheral vascular disease and patients who have had a deep venous or arterial thrombosis (including pulmonary embolism) within 3 months of entry are not eligible
Patients with known allergy to Cremaphor, or Cremophor-based drug products
Patients with any active or uncontrolled infection
Patients with psychiatric disorders that would interfere with consent or follow-up
CPT-11 is known to have teratogenic potential and may be excreted in milk; the current SU5416 Investigator's Brocure indicates that teratogenicity studies have not yet been performed; however, other antiangiogenesis drugs, such as thalidomide, are known to have teratogenic potential; based on the available data, there is potential for significant risk to a developing fetus or breast-feeding child; therefore, pregnant women, women who are breast-feeding, and fertile men and women, unless utilizing birth control are excluded from this study; a negative pregnancy test must be documented during the screening period for women of childbearing potential
Patients with either a prior history of or clinically apparent central nervous system metastases or leptomeningeal carcinomatosis disease
Patients with a history of seizures or who are receiving phenytoin, phenobarbital, or other antipileptic prophylaxis
Patients with uncontrolled diabetes mellitus
Patients with known Gilbert's Disease (may have excessive CPT-11-induced toxicity)
Patients with any other severe concurrent disease which in the judgement of the investigator would make the patient inappropriate for the study
Patients who have received any investigational drug =< 30 days prior to enrollment

Where it is running

M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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