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SU5416 Combined With Gemcitabine and Cisplatin in Treating Patients With Advanced Solid Tumors
This study is ongoing, but not recruiting participants.
First Received: July 5, 2000   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005996
  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 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
Unspecified Adult Solid Tumor, Protocol Specific
Drug: cisplatin
Drug: gemcitabine hydrochloride
Drug: semaxanib
Phase I

MedlinePlus related topics: Cancer
Drug Information available for: Cisplatin Gemcitabine Gemcitabine hydrochloride Semaxanib SU 5416
U.S. FDA Resources
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

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

Detailed Description:

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.

  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 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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005996

Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Study Chair: Lee S. Rosen, MD Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

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

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

Study placed in the following topic categories:
Antimetabolites
Immunologic Factors
Radiation-Sensitizing Agents
Cisplatin
Gemcitabine
Immunosuppressive Agents
Antiviral Agents
SU 5416

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009