Status:
COMPLETED
Vorinostat and Capecitabine in Treating Patients With Metastatic or Unresectable Solid Tumors
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as vorinostat and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vor...
Detailed Description
OBJECTIVES: Primary * Determine the maximum tolerated dose and recommended phase II dose of vorinostat (SAHA) and capecitabine in patients with metastatic or unresectable solid tumors. * Determine t...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed malignant solid tumor
- Metastatic or unresectable disease
- Standard curative or palliative measures do not exist or are no longer effective
- Patients who received prior radiotherapy must have measurable disease outside a previously irradiated field OR disease progression after prior radiotherapy
- No known brain metastases
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- ECOG 0-2 OR
- Karnofsky 60-100%
- Life expectancy
- More than 12 weeks
- Hematopoietic
- WBC ≥ 3,000/mm\^3
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hepatic
- Bilirubin normal
- AST and ALT ≤ 2.5 times upper limit normal (ULN)
- Renal
- Creatinine normal OR
- Creatinine clearance ≥ 60 mL/min
- Cardiovascular
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Able to swallow oral medication
- No clinical or radiological diagnosis of bowel obstruction
- No ongoing or active infection
- No history of allergic reaction attributed to compounds of similar chemical or biological composition to suberoylanilide hydroxamic acid or other agents used in this study
- No known dihydropyrimidine dehydrogenase deficiency
- No psychiatric illness or social situation that would preclude study compliance
- No other uncontrolled illness
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Not specified
- Chemotherapy
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- Prior fluorouracil allowed
- No prior capecitabine
- Endocrine therapy
- Not specified
- Radiotherapy
- See Disease Characteristics
- More than 4 weeks since prior radiotherapy and recovered
- No prior radiotherapy to \> 40% of bone marrow
- Surgery
- At least 4 weeks since prior surgery and recovered
- Other
- At least 2 weeks since prior valproic acid
- No other concurrent investigational agents
- No other concurrent anticancer therapy
- No concurrent combination antiretroviral therapy for HIV-positive patients
Exclusion
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00121277
Start Date
September 1 2005
Last Update
July 23 2015
Active Locations (2)
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1
Ottawa Hospital Regional Cancer Centre - General Campus
Ottawa, Ontario, Canada, K1H 8L6
2
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9