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Phase I Study of SU5416 in Combination With CPT-11 and Cisplatin in Patients With Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Phase I Study of SU5416 in Combination With CPT-11 and Cisplatin in Patients With Solid Tumors


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Eric H. Kraut, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Ohio State University Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068008

NCT ID:

NCT00006000

Start Date:

August 2000

Completion Date:

March 2004

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms

Name

Location

Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210