NCT00331955

Brief Summary

This phase I trial is studying the side effects and best dose of vorinostat when given together with doxorubicin in treating patients with metastatic or locally advanced solid tumors. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may help doxorubicin work better by making tumor cells more sensitive to the drug.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

March 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 31, 2006

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Last Updated

July 2, 2013

Status Verified

July 1, 2013

Enrollment Period

6.3 years

First QC Date

May 30, 2006

Last Update Submit

July 1, 2013

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (2)

  • Safety and tolerability as assessed by NCI CTCAE v3.0

    Up to 30 days after completion of treatment

  • Maximum tolerated dose (MTD) of vorinostat as assessed by NCI CTCAE v3.0

    28 days

Secondary Outcomes (4)

  • Effects of vorinostat on histone acetylation

    At baseline and at day 3 prior

  • Correlation of dose and response with biological markers for histone acetylation, Topo II expression, assays for comet moments and expression patterns of chromatin structural proteins dose

    Up to 30 days after completion of study treatment

  • Response rate (CR and PR) and clinical benefits rate (CR, PR, and stable disease) according to RECIST

    Up to 30 days after completion of study treatment

  • Duration of response (overall response, complete response, and stable disease)

    Up to 30 days after completion of study treatment

Study Arms (1)

Treatment (vorinostat, doxorubicin hydrochloride)

EXPERIMENTAL

Patients receive oral vorinostat twice daily for 5 doses on days 1-3, 8-10, and 15-17 and doxorubicin hydrochloride IV on days 3, 10, and 17. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease after 6 courses of treatment may continue to receive vorinostat alone in the absence of disease progression.

Drug: doxorubicin hydrochlorideDrug: vorinostatOther: pharmacological studyOther: laboratory biomarker analysis

Interventions

doxorubicin hydrochlorideDRUG

Given IV

Also known as: ADM, ADR, Adria, Adriamycin PFS, Adriamycin RDF
Treatment (vorinostat, doxorubicin hydrochloride)
vorinostatDRUG

Given orally

Also known as: L-001079038, SAHA, suberoylanilide hydroxamic acid, Zolinza
Treatment (vorinostat, doxorubicin hydrochloride)
pharmacological studyOTHER

Correlative studies

Also known as: pharmacological studies
Treatment (vorinostat, doxorubicin hydrochloride)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (vorinostat, doxorubicin hydrochloride)

Eligibility Criteria

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

You may qualify if:

  • Histologically or cytologically confirmed solid tumor malignancies for which no curative therapy exists
  • Measurable or evaluable disease with tumor that is accessible to biopsy as determined by CT scan or ultrasound
  • Skin, lymph nodes, or chest wall lesions are allowed provided measurements are confirmed by 2 independent health care professionals
  • No uncontrolled CNS metastases
  • Patients with stable CNS metastases (either surgically resected, treated with gamma knife, or stable for 3 months after whole-brain radiotherapy and documented by MRI within the past 4 weeks) are eligible
  • Willing to undergo pre- and post-vorinostat tumor biopsies
  • Life expectancy ≥ 3 months
  • ECOG performance status 0-2
  • WBC \> 3,000/mm\^3
  • Absolute neutrophil count \> 1,500/mm\^3
  • Hemoglobin \> 9.0 g/dL
  • Platelet count \> 100,000/mm\^3 (transfusion independent)
  • Creatinine ≤ 2.0 mg/mL
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST and ALT ≤ 1.5 times ULN
  • +19 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

MeSH Terms

Interventions

DoxorubicinVorinostat

Intervention Hierarchy (Ancestors)

DaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesAnilidesAmidesAniline CompoundsAminesHydroxamic AcidsHydroxylaminesHydroxy AcidsCarboxylic Acids

Study Officials

  • Robert Wenham

    H. Lee Moffitt Cancer Center and Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 30, 2006

First Posted

May 31, 2006

Study Start

March 1, 2006

Primary Completion

June 1, 2012

Last Updated

July 2, 2013

Record last verified: 2013-07

Locations

US(1)