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Sponsors and Collaborators: |
Jonsson Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005996 |
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 more than once chemotherapy drug with SU5416 may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of SU5416 combined with gemcitabine and cisplatin in treating patients who have advanced solid tumors.
Condition | Intervention | Phase |
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Unspecified Adult Solid Tumor, Protocol Specific |
Drug: cisplatin Drug: gemcitabine hydrochloride Drug: semaxanib |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
Study ID Numbers: | CDR0000068000, UCLA-0002046, SUGEN-ND019901/SE5416.102, NCI-G00-1805 |
Study First Received: | July 5, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00005996 History of Changes |
Health Authority: | United States: Federal Government |
unspecified adult solid tumor, protocol specific |
Antimetabolites Immunologic Factors Radiation-Sensitizing Agents Cisplatin |
Gemcitabine Immunosuppressive Agents Antiviral Agents SU 5416 |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors |
Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Cisplatin Radiation-Sensitizing Agents Therapeutic Uses Gemcitabine |