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SU5416 and Irinotecan in Treating Patients With Advanced Colorectal Cancer
This study has been completed.
First Received: June 2, 2000   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005818
  Purpose

RATIONALE: 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.

PURPOSE: Phase I/II trial to study the effectiveness of combining SU5416 and irinotecan in treating patients who have advanced colorectal cancer.


Condition Intervention Phase
Colorectal Cancer
Drug: irinotecan hydrochloride
Drug: semaxanib
Phase I
Phase II

MedlinePlus related topics: Cancer Colorectal Cancer
Drug Information available for: Irinotecan U 101440E Irinotecan hydrochloride Semaxanib SU 5416
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Phase I-II Study of Escalating Doses of SU5416 (NSC 696819) in Combination With CPT-11 in Patients With Advanced Colorectal Carcinoma

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

Study Start Date: June 2000
Detailed Description:

OBJECTIVES: I. Determine the maximum tolerated dose (MTD) and dose-limiting toxicity of SU5416 in combination with irinotecan in patients with advanced colorectal cancer. II. Determine time to disease progression, objective response rate, and survival time in these patients receiving this regimen at the MTD. III. Evaluate the safety and tolerance of this regimen in these patients.

OUTLINE: This is a dose-escalation study of SU5416. 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. Cohorts of 3-6 patients receive escalating doses of SU5416 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are accrued to receive treatment with SU5416 and irinotecan at the recommended phase II dose. Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for the phase I portion of this study within 12 months. An additional 44 patients will be accrued for the phase II portion of this study within 7 months.

  Eligibility

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

DISEASE CHARACTERISTICS: Histologically confirmed locally advanced or metastatic adenocarcinoma of the colon or rectum not amenable to potentially curative treatment Measurable or evaluable disease Measurable disease defined as at least 1 bidimensionally measurable lesion at least 1 x 1 cm that is outside field of any prior radiotherapy Must have received a prior chemotherapy regimen containing a fluorinated pyrimidine No more than 2 prior chemotherapy regimens for locally advanced or metastatic disease in phase I and only 1 prior chemotherapy regimen for locally advanced or metastatic disease in phase II If progression while on or within 6 months of adjuvant therapy, the adjuvant regimen is considered treatment for metastatic disease No history of or clinically apparent CNS metastases or leptomeningeal carcinomatosis disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 3 times upper limit of normal No known Gilbert's disease Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No uncompensated coronary artery disease on electrocardiogram or physical examination No history of myocardial infarction No severe/unstable angina in the past 6 months No deep venous or arterial thrombosis within past 3 months Pulmonary: No pulmonary embolism within past 3 months Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study History of prior malignancy allowed (phase I only) No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer (phase II) No uncontrolled diabetes mellitus No known allergy to Cremophor or Cremophor-based drug products No active or uncontrolled infection No psychiatric disorders that would preclude study No history of seizures No other severe concurrent disease that would preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: No prophylactic hematopoietic growth factors (e.g., filgrastim (G-CSF)) No concurrent biologic therapy Chemotherapy: See Disease Characteristics No prior SU5416, irinotecan, or any topoisomerase I inhibitor No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery: At least 4 weeks since prior major surgery and recovered Other: At least 30 days since other prior investigational drugs No concurrent phenytoin, phenobarbital, or other antiepileptic prophylaxis No concurrent prochlorperazine on day of irinotecan administration No other concurrent anticancer therapy

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005818

Locations
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: James L. Abbruzzese, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000067823, MDA-ID-99243, NCI-88
Study First Received: June 2, 2000
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00005818     History of Changes
Health Authority: United States: Federal Government

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

Study placed in the following topic categories:
Digestive System Neoplasms
Rectal Neoplasms
Gastrointestinal Diseases
Irinotecan
Colonic Diseases
Rectal Neoplasm
Intestinal Diseases
Rectal Diseases
Camptothecin
SU 5416
Recurrence
Intestinal Neoplasms
Carcinoma
Rectal Cancer
Digestive System Diseases
Gastrointestinal Neoplasms
Adenocarcinoma
Antineoplastic Agents, Phytogenic
Colorectal Neoplasms

Additional relevant MeSH terms:
Digestive System Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gastrointestinal Diseases
Colonic Diseases
Irinotecan
Enzyme Inhibitors
Intestinal Diseases
Rectal Diseases
Pharmacologic Actions
Intestinal Neoplasms
Camptothecin
Neoplasms
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Gastrointestinal Neoplasms
Antineoplastic Agents, Phytogenic
Colorectal Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009