S-3304 in Treating Patients With Advanced Solid Tumors

• Status: Completed
• Trial end date: 2003-01-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: S-3304 may stop or slow the growth of solid tumors by stopping blood flow to the tumor.

PURPOSE: Phase I trial to study the effectiveness of S-3304 in treating patients who have solid tumors.

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

Details

• Lead Sponsor: Roswell Park Cancer Institute
• Treatments: S 3304

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed solid tumor that failed to respond or relapsed after prior therapy or for which no standard therapy exists

• Biopsy-accessible lesion

• No brain metastasis unless clinically stable and off therapy

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• More than 6 weeks

Hematopoietic:

• Absolute neutrophil count greater than 1,500/mm^3

• Platelet count at least 100,000/mm^3

• Hemoglobin at least 9.0 g/dL

Hepatic:

• Bilirubin no greater than 2 times upper limit of normal (ULN)

• Transaminases less than 2.5 times ULN

Renal:

• Creatinine less than 2.0 mg/dL

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for at least 30 days after study

• Able to tolerate oral medication

• HIV negative

• No AIDS

• No serious underlying gastrointestinal disorders (e.g., recurrent vomiting or inflammatory bowel disease)

• No other serious concurrent illness

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 4 weeks since prior immunotherapy

• Concurrent stable doses of epoetin alfa are allowed during the second and subsequent courses

• No other concurrent immunotherapy

Chemotherapy:

• At least 4 weeks since prior chemotherapy

• No concurrent chemotherapy

Endocrine therapy:

• At least 4 weeks since prior hormonal therapy

• Concurrent stable doses of steroids for prostate cancer are allowed during the second and subsequent courses

• No concurrent hormonal therapy

Radiotherapy:

• At least 4 weeks since prior radiotherapy

• No concurrent radiotherapy

Surgery:

• No prior significant gastric resection

Other:

• Recovered from prior therapy

• At least 4 weeks since other prior investigational antitumor drugs

• No other concurrent investigational antitumor drugs

• Concurrent stable doses of bisphosphonates, cyclo-oxygenase-2 inhibitors, and non-steroidal anti-inflammatory drugs are allowed during the second and subsequent study courses