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Vorinostat, Paclitaxel, and Carboplatin in Treating Patients With Advanced or Refractory Solid Tumors
This study is ongoing, but not recruiting participants.
First Received: February 6, 2006   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: UPMC Cancer Centers
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00287937
  Purpose

RATIONALE: 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.

PURPOSE: 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.


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: carboplatin
Drug: paclitaxel
Drug: vorinostat
Phase I

MedlinePlus related topics: Cancer
Drug Information available for: Paclitaxel Carboplatin Suberoylanilide hydroxamic acid
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I Study Of Suberoylanilide Hydroxamic Acid (SAHA) (NSC 701852) in Combination With Paclitaxel /Carboplatin for Advanced and Refractory Solid Malignancies

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 30
Study Start Date: July 2005
Detailed Description:

OBJECTIVES:

Primary

  • Determine the recommended phase II dose of vorinostat (SAHA) when administered with paclitaxel and carboplatin in patients with advanced or refractory solid tumors.

Secondary

  • Determine the dose-limiting toxicity (DLT) and other toxic effects of this regimen in these patients.
  • Assess, preliminarily, evidence of antitumor activity of this regimen in these patients.
  • Determine the pharmacokinetic parameters of this regimen in these patients.
  • Determine the in vivo effects of this regimen in these patients.

OUTLINE: This is a multicenter, dose-escalation study of vorinostat (SAHA).

Patients receive oral SAHA once or twice daily on days 1-14* and paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1.

Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who have stable disease after the completion of 6 courses may receive single-agent SAHA at the discretion of the treating physician.

NOTE: *During the first treatment course only, patients receive SAHA on days -4 to 10.

Cohorts of 3-6 patients receive escalating doses of SAHA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience DLT. An additional 6-12 patients are treated at the MTD.

After completion of study treatment, patients are followed at 1 month.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00287937

Locations
United States, Pennsylvania
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
UPMC Cancer Centers
Investigators
Study Chair: Suresh Ramalingam, MD UPMC Cancer Centers
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000454713, PCI-PHI-51, PCI-UPC-04-170, PCI-0504020, NCI-6922
Study First Received: February 6, 2006
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00287937     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

Study placed in the following topic categories:
Anti-Inflammatory Agents
Anticarcinogenic Agents
Vorinostat
Carboplatin
Antimitotic Agents
Paclitaxel
Analgesics, Non-Narcotic
Tubulin Modulators
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Antineoplastic Agents, Phytogenic

Additional relevant MeSH terms:
Anticarcinogenic Agents
Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Vorinostat
Mitosis Modulators
Enzyme Inhibitors
Carboplatin
Antimitotic Agents
Protective Agents
Pharmacologic Actions
Sensory System Agents
Paclitaxel
Analgesics, Non-Narcotic
Therapeutic Uses
Tubulin Modulators
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 07, 2009