Combination Chemotherapy in Treating Patients With Solid Tumors

• Status: Unknown status
• Trial end date: 1969-12-31
• 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 fenretinide, paclitaxel, and cisplatin in treating patients who have solid tumors that have not responded to previous therapy.

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

Details

• Lead Sponsor: Ohio State University Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Cisplatin; Fenretinide; Paclitaxel

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically proven refractory solid tumor for which paclitaxel and cisplatin are reasonable therapeutic options

• No active CNS disease

• CNS metastasis allowed if measurable disease outside of the CNS and patient completed and recovered from 1 prior course of CNS radiotherapy (if clinically indicated)

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2 OR

• Zubrod 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Platelet count at least 100,000/mm3

• Absolute neutrophil count at least 1,500/mm3

Hepatic:

• Bilirubin no greater than 2.0 mg/dL

• ALT and AST no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if related to liver metastases)

Renal:

• Creatinine no greater than 1.5 mg/dL

Cardiovascular:

• No severe symptomatic cardiac disease

Other:

• No clinically significant/evident retinopathy

• No other malignancy within the past 5 years except localized nonmelanoma skin cancer or carcinoma in situ of the cervix

• No uncontrolled infection

• No other significant medical or psychiatric condition that would increase risk

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception for 1 month before, during, and for at least 2 months after study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics

• No prior paclitaxel, cisplatin, or fenretinide

• At least 4 weeks since other prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics

• At least 4 weeks since prior radiotherapy to only site of measurable/evaluable disease

• No prior radiotherapy to more than 25% of bone marrow

Surgery:

• At least 2 weeks since prior therapeutic surgery and recovered

Other:

• At least 4 weeks since prior routine vitamin A of at least 10,000 IU/ day or beta carotene of at least 10 mg/day