Tirapazamine, Carboplatin, and Paclitaxel in Treating Patients With Advanced Malignant Solid Tumors

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combining tirapazamine, carboplatin, and paclitaxel in treating patients who have advanced malignant solid tumors.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: City of Hope Medical Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel; Tirapazamine

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed advanced or metastatic malignant solid tumor not curable by resection or other standard therapy

• No symptomatic brain metastases

• Brain metastases allowed provided controlled with surgical excision and/or radiotherapy

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• At least 3 months

Hematopoietic:

• WBC at least 3,000/mm3

• Absolute neutrophil count at least 1,000/mm3

• Platelet count at least 100,000/mm3

Hepatic:

• Bilirubin no greater than 1.5 mg/dL

• SGOT no greater than 2 times upper limit of normal

Renal:

• Creatinine normal

• Creatinine clearance at least 60 mL/min

Cardiovascular:

• No New York Heart Association class III or IV congestive heart failure

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 3 months after study

• No history of allergic reactions to appropriate diuretics or antiemetics administered in conjunction with protocol chemotherapy (e.g., 5-HT3 antagonists)

• No other concurrent uncontrolled illness that would preclude study therapy

• No medical, social, or psychological factors that would preclude study therapy

• No clinically significant hearing loss

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• At least 4 weeks since prior chemotherapy (6 weeks for mitomycin and nitrosoureas) and recovered

• No more than 2 prior chemotherapy regimens

• No prior combination paclitaxel and carboplatin

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics

• At least 4 weeks since prior radiotherapy and recovered

• No concurrent radiotherapy

Surgery:

• See Disease Characteristics

• Recovered from prior surgery

Other:

• At least 30 days since other prior investigational drugs

• No other concurrent anticancer therapy

• No other concurrent investigational agents