- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00287937
Vorinostat, Paclitaxel, and Carboplatin in Treating Patients With Advanced or Refractory Solid Tumors
Phase I Study Of Suberoylanilide Hydroxamic Acid (SAHA) (NSC 701852) in Combination With Paclitaxel /Carboplatin for Advanced and Refractory Solid Malignancies
Study Overview
Status
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. Determine the recommended phase II dose of vorinostat (SAHA) when administered with paclitaxel and carboplatin in patients with advanced or refractory solid tumors.
SECONDARY OBJECTIVES:
I. Determine the dose-limiting toxicity (DLT) and other toxic effects of this regimen in these patients.
II. Assess, preliminarily, evidence of antitumor activity of this regimen in these patients.
III. Determine the pharmacokinetic parameters of this regimen in these patients.
IV. 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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15232
- University of Pittsburgh
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (vorinostat, paclitaxel, carboplatin)
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.
|
Correlative studies
Correlative studies
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Given orally
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
MTD of vorinostat defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience DLT
Time Frame: 21 days
|
21 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Toxicity graded using the CTC version 2.0
Time Frame: Up to 1 month after completion of study treatment
|
Tables will be created to summarize these toxicities by dose and by course.
|
Up to 1 month after completion of study treatment
|
Overall survival
Time Frame: Up to 1 month after completion of study treatment
|
Summarized with Kaplan-Meier plots.
|
Up to 1 month after completion of study treatment
|
Time to failure
Time Frame: Up to 1 month after completion of study treatment
|
Summarized with Kaplan-Meier plots.
|
Up to 1 month after completion of study treatment
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Response defined using the RECIST criteria
Time Frame: Up to 1 month after completion of study treatment
|
Up to 1 month after completion of study treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Suresh Ramalingam, University of Pittsburgh
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCI-2012-02676
- U01CA099168 (U.S. NIH Grant/Contract)
- U01CA062505 (U.S. NIH Grant/Contract)
- PHI 51
- CDR0000454713 (Registry Identifier: PDQ (Physician Data Query))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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