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A Phase I Study of SU5416 in Combination With Gemcitabine/Cisplatin in Patients With Advanced Solid Tumors

Phase 1
18 Years
Open (Enrolling)
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A Phase I Study of SU5416 in Combination With Gemcitabine/Cisplatin in Patients With Advanced Solid Tumors

OBJECTIVES: I. Assess the toxicities and pharmacokinetics of SU5416 when combined with
gemcitabine and cisplatin in patients with advanced solid tumors. II. Determine the
antitumor activity of this combination treatment regimen in this patient population.

OUTLINE: This is an open label, dose escalation study of SU5416. Patients receive
gemcitabine IV over 30 minutes followed by cisplatin IV over 1 hour on day 1; SU5416 IV over
70 minutes on day 4; gemcitabine IV over 30 minutes followed by SU5416 IV over 70 minutes on
day 8, and SU5416 on days 11, 15, and 18. Treatment repeats every 3 weeks for a maximum of 6
courses in the absence of disease progression or unacceptable toxicity. Following 6 courses
of therapy, patients with stable and responsive disease may receive SU5416 alone on days 1,
4, 8, 11, 15, and 18 every 3 weeks for a maximum of 1 year. 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 at least one third of the patients experience
dose limiting toxicity. Patients are followed at 1 month, and then every 3 months.

PROJECTED ACCRUAL: A total of 16-30 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven advanced solid tumor that may respond to
gemcitabine and cisplatin therapy (e.g., esophagus, head and neck, breast, ovary, bladder,
or non-small cell lung cancer) No brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count
at least 100,000/mm3 Hemoglobin at least 8.8 g/dL Hepatic: Bilirubin less than 2.05 mg/dL
Renal: Creatinine no greater than 1.8 mg/dL OR Creatinine clearance at least 50 mL/min
Cardiovascular: No prior myocardial infarction No severe or unstable angina No history of
atherosclerotic coronary artery disease requiring coronary or peripheral artery bypass
surgery or concurrent medication No history of arrhythmias, hypertension, or deep venous
thrombosis No clinical evidence of severe peripheral vascular disease related to diabetes
mellitus Pulmonary: No history of lung embolism Other: No known allergy to Cremophor or
Cremophor based drug products No contraindications to systemic gemcitabine or cisplatin
therapy No insulin dependent or noninsulin dependent diabetes mellitus with clinical
evidence of diabetic ulcers No other active malignancies except basal cell skin cancer or
carcinoma in situ of the cervix No other acute or chronic medical or psychiatric condition
or laboratory abnormality that would preclude study Not pregnant or nursing Negative
pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 2 weeks since prior epoetin alfa,
filgrastim (G-CSF), or sargramostim (GM-CSF) No prior antiangiogenesis therapy No prior
SU5416 No concurrent immunotherapy Chemotherapy: See Disease Characteristics No more than
1 prior systemic chemotherapy regimen allowed At least 4 weeks since prior systemic
chemotherapy (6 weeks for mitomycin or nitrosourea) No prior high dose chemotherapy At
least 6 months since prior gemcitabine and cisplatin and responsive No other concurrent
chemotherapy Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: At
least 4 weeks since prior surgery Other: No other concurrent investigational agents

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Lee S. Rosen, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Jonsson Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

Completion Date:

Related Keywords:

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