SU5416 and Irinotecan in Treating Patients With Advanced Colorectal Cancer

NCT00005818 | Completed Phase 1

• 4 other identifiers: NCI-2012-02330ID-99-243N01CM17003CDR0000067823
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Time to disease progression (TTP)

  Estimated using the Kaplan-Meier method. Associated 95% confidence intervals will be computed.

  6 months

Secondary Outcomes (3)

• Overall tumor response rate (CR + PR)

  Up to 3 years

• Overall survival

  From date of entry on study to the date of death of the patients; assessed up to 3 years

• Toxicity graded using the NCI CTC version 2.0

  Up to 3 years

Study Arms (1)

Treatment (irinotecan hydrochloride, semaxanib)

EXPERIMENTAL

Patients receive irinotecan IV over 90 minutes on day 1 of weeks 1-4 and SU5416 IV over 60 minutes on days 1 and 4 of weeks 1-6. Treatment continues every 6 weeks in the absence of unacceptable toxicity or disease progression.

Drug: irinotecan hydrochloride; Drug: semaxanib; Other: laboratory biomarker analysis

Interventions

irinotecan hydrochloride DRUG

Given IV

Also known as: Campto, Camptosar, CPT-11, irinotecan, U-101440E

Treatment (irinotecan hydrochloride, semaxanib)

semaxanib DRUG

Given IV

Also known as: semoxind, SU5416, Sugen 5416

Treatment (irinotecan hydrochloride, semaxanib)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (irinotecan hydrochloride, semaxanib)

Eligibility Criteria

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

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

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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms; Rectal Neoplasms

Interventions

Irinotecan; Semaxinib

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• James Abbruzzese

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2000
• First Posted: May 5, 2003
• Study Start: March 1, 2000
• Primary Completion: March 1, 2003
• Last Updated: January 23, 2013

Record last verified: 2013-01

Locations

US (1)