SU5416, Irinotecan, and Cisplatin in Treating Patients With Advanced Solid Tumors

NCT00006000 | Completed Phase 1

• 3 other identifiers: CDR0000068008OSU-00H0033NCI-47
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

cisplatin DRUG

irinotecan hydrochloride DRUG

semaxanib DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Arthur G. James Cancer Hospital - Ohio State University

Columbus, Ohio, 43210-1240, United States

Location

MeSH Terms

Interventions

Cisplatin; Irinotecan; Semaxinib

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Eric H. Kraut, MD

  Ohio State University Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 5, 2000
• First Posted: March 5, 2004
• Study Start: August 1, 2000
• Study Completion: March 1, 2004
• Last Updated: January 31, 2013

Record last verified: 2002-01

Locations

US (1)