PS-341 and Combination Chemotherapy in Treating Patients With Advanced Solid Tumors

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Phase I trial to study the effectiveness of combining PS-341 and combination chemotherapy in treating patients who have advanced solid tumors. PS-341 may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining PS-341 and chemotherapy may kill more tumor cells

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

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Bortezomib; Carboplatin; Paclitaxel; Proteasome Inhibitors

Criteria

Inclusion Criteria:

• Histologically confirmed malignancy for which no known standard therapy that is potentially curative or definitely capable of extending life expectancy exists

• No hematologic malignancies

• No symptomatic CNS metastases

• Brain metastases allowed if previously treated (radiotherapy and/or surgery)and patient is stable for at least 8 weeks

• Performance status - ECOG 0-2

• At least 12 weeks

• Absolute neutrophil count at least 1,500/mm^3

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

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)

• AST no greater than 2.5 times ULN

• Creatinine no greater than 1.5 times ULN

• No New York Heart Association class III or IV heart disease

• HIV negative

• No peripheral neuropathy grade 2 or greater

• No uncontrolled infection

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• More than 4 weeks since prior biologic therapy

• More than 4 weeks since prior immunotherapy

• No prior bone marrow transplantation

• No concurrent immunotherapy

• More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered

• No other concurrent chemotherapy

• More than 4 weeks since prior radiotherapy

• No prior radiotherapy to more than 30% of bone marrow

• No concurrent radiotherapy

• No concurrent investigational ancillary therapy

• No concurrent enrollment in another study involving a pharmacologic agent (e.g., drugs, biologics, immunotherapy, or gene therapy) for symptom control or therapeutic intents