NCT00121277

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 21, 2005

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2005

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Last Updated

July 23, 2015

Status Verified

July 1, 2015

Enrollment Period

3.9 years

First QC Date

July 19, 2005

Last Update Submit

July 22, 2015

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (2)

  • Maximum tolerated doses of vorinostat (SAHA) and capecitabine

    1 cycle

  • Safety and tolerability as assessed by CTCAE v3.0

    All cycles

Secondary Outcomes (3)

  • Response rate as assessed by RECIST criteria

    Every 2 cycles

  • Molecular markers as assessed by molecular analysis

    Cycle 1

  • Survival

    progression free survival every 2 cycles

Study Arms (1)

SAHA (Suberoylanilide Acid) with Capecitabine

EXPERIMENTAL
Drug: capecitabineDrug: vorinostat

Interventions

capecitabineDRUG
SAHA (Suberoylanilide Acid) with Capecitabine
vorinostatDRUG
SAHA (Suberoylanilide Acid) with Capecitabine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Ottawa Hospital Regional Cancer Centre - General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Interventions

CapecitabineVorinostat

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesHydroxamic AcidsHydroxylaminesHydroxy AcidsCarboxylic Acids

Study Officials

  • Eric X. Chen, MD, PhD

    Princess Margaret Hospital, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2005

First Posted

July 21, 2005

Study Start

September 1, 2005

Primary Completion

August 1, 2009

Last Updated

July 23, 2015

Record last verified: 2015-07

Locations

CA(2)