Vorinostat, Paclitaxel, and Carboplatin in Treating Patients With Advanced or Refractory Solid Tumors

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

Summary

This phase I trial is studying the side effects and best dose of vorinostat when given together with paclitaxel and carboplatin in treating patients with advanced or refractory solid tumors. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving vorinostat together with paclitaxel and carboplatin may kill more tumor cells

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

Details

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

Criteria

Inclusion Criteria:

• Histologically confirmed solid tumor

• No untreated brain metastases

• Patients with stable brain disease (no concurrent corticosteroids) ≥ 4 weeks after completion of appropriate therapy are eligible

• ECOG performance status ≤ 2 OR Karnofsky performance status 60-100%

• Life expectancy > 12 weeks

• WBC ≥ 3,000/mm^3

• Absolute neutrophil count ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

• Bilirubin normal

• AST/ALT ≤ 2.5 times upper limit of normal

• Creatinine within normal institutional limits OR creatinine clearance ≥ 60 mL/min

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective double barrier contraception for at least 1 week before, during, and for at least 2 weeks after study participation

• No peripheral neuropathy > grade 1

• No history of allergic reactions to paclitaxel

• No history of allergic reactions attributed to compounds of similar chemical or biologic composition to study drugs

• No inability to take oral medications on a continuous basis

• No psychiatric illness or social situation that would limit compliance with this study

• No ongoing or active infection

• No symptomatic congestive heart failure

• No unstable angina pectoris

• No cardiac arrhythmia

• No other uncontrolled illness

• No more than 2 prior chemotherapy regimens for advanced/metastatic disease

• Adjuvant chemotherapy administered ≥ 2 years prior to study entry is not considered a prior chemotherapy regimen for purposes of this study

• No prior therapy with paclitaxel

• No chemotherapy or radiotherapy within the past 3 weeks (6 weeks for nitrosoureas or mitomycin C) and recovered

• At least 4 weeks since prior valproic acid

• No other concurrent anticancer therapies or agents

• No other concurrent investigational agents

• No concurrent combination antiretroviral therapy for HIV-positive patients

• No concurrent oral contraceptives

• No concurrent prophylactic growth factors