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Vorinostat and Capecitabine in Treating Patients With Metastatic or Unresectable Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00121277
Recruitment Status : Completed
First Posted : July 21, 2005
Last Update Posted : July 23, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University Health Network, Toronto

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. Vorinostat may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of vorinostat and capecitabine in treating patients with unresectable or metastatic solid tumors.

Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Drug: capecitabine Drug: vorinostat Phase 1

Detailed Description:



  • Determine the maximum tolerated dose and recommended phase II dose of vorinostat (SAHA) and capecitabine in patients with metastatic or unresectable solid tumors.
  • Determine the safety and tolerability of this regimen in these patients.


  • Correlate the clinical effects with the pharmacokinetic effects of this regimen in these patients.

OUTLINE: This is a dose-escalation, multicenter study.

Patients receive oral vorinostat (SAHA) once or twice daily and oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for at least 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 courses beyond documentation of CR. Patients achieving a partial response receive 2 courses beyond documentation of best response.

Cohorts of 3-6 patients receive escalating doses of SAHA and capecitabine 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 dose-limiting toxicity. An additional 12 patients are treated at the MTD.

After completion of study treatment, patients are followed at 3-4 weeks and then every 3 months thereafter.

PROJECTED ACCRUAL: Approximately 18-30 patients will be accrued for this study within 6-10 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Suberoylanilide Hydroxamic Acid (SAHA) in Combination With Capecitabine in Patients With Solid Tumors
Study Start Date : September 2005
Actual Primary Completion Date : August 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: SAHA (Suberoylanilide Acid) with Capecitabine Drug: capecitabine
Drug: vorinostat

Primary Outcome Measures :
  1. Maximum tolerated doses of vorinostat (SAHA) and capecitabine [ Time Frame: 1 cycle ]
  2. Safety and tolerability as assessed by CTCAE v3.0 [ Time Frame: All cycles ]

Secondary Outcome Measures :
  1. Response rate as assessed by RECIST criteria [ Time Frame: Every 2 cycles ]
  2. Molecular markers as assessed by molecular analysis [ Time Frame: Cycle 1 ]
  3. Survival [ Time Frame: progression free survival every 2 cycles ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy

  • More than 12 weeks


  • WBC ≥ 3,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3


  • Bilirubin normal
  • AST and ALT ≤ 2.5 times upper limit normal (ULN)


  • Creatinine normal OR
  • Creatinine clearance ≥ 60 mL/min


  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia


  • 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


Biologic therapy

  • Not specified


  • 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


  • See Disease Characteristics
  • More than 4 weeks since prior radiotherapy and recovered
  • No prior radiotherapy to > 40% of bone marrow


  • At least 4 weeks since prior surgery and recovered


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00121277

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Canada, Ontario
Ottawa Hospital Regional Cancer Centre - General Campus
Ottawa, Ontario, Canada, K1H 8L6
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
National Cancer Institute (NCI)
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Principal Investigator: Eric X. Chen, MD, PhD Princess Margaret Hospital, Canada

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Responsible Party: University Health Network, Toronto Identifier: NCT00121277     History of Changes
Other Study ID Numbers: PMH-PHL-035
CDR0000434850 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: July 21, 2005    Key Record Dates
Last Update Posted: July 23, 2015
Last Verified: July 2015
Keywords provided by University Health Network, Toronto:
unspecified adult solid tumor, protocol specific
Additional relevant MeSH terms:
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Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Histone Deacetylase Inhibitors
Enzyme Inhibitors