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SU5416, Irinotecan, and Cisplatin in Treating Patients With Advanced Solid Tumors
This study has been completed.
Sponsors and Collaborators: Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006000
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. SU5416 may stop the growth of solid tumors by stopping blood flow to the tumor. Combining SU5416 with chemotherapy may kill more cancer cells.

PURPOSE: Phase I trial to study the effectiveness of SU5416 plus irinotecan and cisplatin in treating patients who have advanced solid tumors.


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: cisplatin
Drug: irinotecan hydrochloride
Drug: semaxanib
Phase I

MedlinePlus related topics: Cancer
Drug Information available for: Cisplatin Irinotecan Irinotecan hydrochloride Semaxanib SU 5416
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I Study of SU5416 in Combination With CPT-11 and Cisplatin in Patients With Solid Tumors

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

Study Start Date: August 2000
Detailed Description:

OBJECTIVES: I. Determine the maximum tolerated dose of SU5416 in combination with irinotecan and cisplatin in patients with advanced solid tumors. II. Determine the quantitative and qualitative toxicity of this treatment regimen in terms of organ specificity, time course, predictability, and reversibility in this patient population. III. Determine the therapeutic response of this treatment regimen in these patients. IV. Evaluate the clinical pharmacokinetics and the relationship of kinetics to toxicity and response in this patient population treated with this regimen.

OUTLINE: This is a dose escalation study of SU5416. Patients receive cisplatin IV over 90 minutes immediately followed by irinotecan IV over 90 minutes and SU5416 IV over 2 hours on day 1. Patients receive SU5416 alone on day 4. Patients receive combination chemotherapy weekly for 4 weeks and SU5416 twice weekly for 6 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of SU5416 until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity.

PROJECTED ACCRUAL: A total of 3-24 patients 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 proven advanced solid tumor for which no curative therapy exists No prior or concurrent primary brain tumor or brain metastasis

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-1 Life expectancy: At least 12 weeks Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 No inherited predisposition to hypercoagulation Hepatic: Bilirubin normal SGOT no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No uncompensated coronary artery disease on electrocardiogram or physical examination No myocardial infarction or severe unstable angina within the past 6 months No severe peripheral vascular disease related to diabetes mellitus No deep venous or arterial thrombosis within the past 3 months No inherited predisposition to thrombosis Pulmonary: No pulmonary embolism within the past 3 months Other: No other malignancies within the past 5 years except basal or squamous cell skin cancer or carcinoma in situ of the cervix No other significant medical illness No serious active infections Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy and recovered No concurrent biologic therapy Chemotherapy: At least 4 weeks since prior chemotherapy and recovered No other concurrent chemotherapy No prior cisplatin or irinotecan Endocrine therapy: At least 4 weeks since prior hormonal therapy and recovered No concurrent hormonal therapy Radiotherapy: At least 4 weeks since prior radiotherapy to less than 25% bone marrow and recovered No concurrent radiotherapy Surgery: At least 4 weeks since prior surgery and recovered No concurrent surgery Other: No other concurrent investigational drugs

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006000

Locations
United States, Ohio
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States, 43210-1240
Sponsors and Collaborators
Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
Investigators
Study Chair: Eric H. Kraut, MD Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
  More Information

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

Study ID Numbers: CDR0000068008, OSU-00H0033, NCI-47
Study First Received: July 5, 2000
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00006000  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

Study placed in the following topic categories:
Cisplatin
Irinotecan
Camptothecin
SU 5416

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Radiation-Sensitizing Agents
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009