VX-853 in Treating Patients With Solid Tumors Who Are Receiving Liposomal Doxorubicin

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Georgetown University
ClinicalTrials.gov Identifier:
NCT00004030
First received: December 10, 1999
Last updated: March 22, 2011
Last verified: January 2001
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I/II trial to study the effectiveness of VX-853 in treating patients who have solid tumors who are receiving liposomal doxorubicin.


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: VX-853
Drug: pegylated liposomal doxorubicin hydrochloride
Phase 1
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I/II Study of the Pharmacokinetics, Tolerability and Safety of Administration of VX-853 to Patients Receiving Single Agent Therapy With Doxorubicin HCI

Resource links provided by NLM:


Further study details as provided by Georgetown University:

Estimated Enrollment: 45
Study Start Date: March 1996
Study Completion Date: January 2001
Primary Completion Date: January 2001 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES: I. Determine the safety and tolerability of VX-853 in combination with doxorubicin HCl liposome in patients with relapsed or incurable solid tumors. II. Obtain pharmacokinetic profiles for various dosages of VX-853 administered in combination with doxorubicin HCl liposome. III. Achieve whole blood concentrations of VX-853 in the predicted therapeutically effective range and characterize the pharmacokinetics at these doses. IV. Document antitumor effects of VX-853 in combination with doxorubicin HCl liposome in these patients.

OUTLINE: This is a dose escalation study of VX-853. Patients receive VX-853 orally every 8 hours on days 1-3 and doxorubicin HCL liposome IV over approximately 15 minutes beginning 26 hours after starting VX-853. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of VX-853 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 or more of 6 patients experience dose limiting toxicity.

PROJECTED ACCRUAL: A maximum of 45 patients will be accrued for this study within approximately 18 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically proven relapsed or incurable solid tumors No primary or metastatic CNS disease

PATIENT CHARACTERISTICS: See General Eligibility Criteria

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 3 weeks since prior cytotoxic chemotherapy (6 weeks since prior mitomycin or nitrosourea) Prior doxorubicin HCl allowed (no extensive therapy) Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Prior surgery allowed Other: Recovered from toxic effects of prior therapy At least 4 weeks since prior investigational or approved clinical trial agents No concurrent cimetidine, phenothiazines, phenytoin, calcium channel blockers, or cyclosporine or other P-glycoprotein inhibitors --Patients Characteristics-- Age: 18 and over Performance Status: Karnofsky 70-100% Life Expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Hemoglobin at least 9.0 g/dL Platelet count at least 100,000/mm3 Hepatic: AST and/or ALT no greater than 2 times upper limit of normal Bilirubin normal Renal: Creatinine normal Creatinine clearance at least 60 mL/min Cardiovascular: No clinically significant EKG abnormalities No atrial or ventricular arrhythmias requiring medication No ischemic event within 6 months of study Cardiac ejection fraction at least 50% by MUGA scan Other: Not pregnant or nursing Fertile patients must use effective contraception No prior or concurrent seizure disorders No prior or concurrent clinically significant medical illness No known hypersensitivity to doxorubicin HCl or other study medications No other active malignancies except curatively treated carcinoma in situ of the cervix or basal cell skin cancer

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004030

Locations
United States, District of Columbia
Vincent T. Lombardi Cancer Research Center, Georgetown University
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
Investigators
Study Chair: Michael J. Hawkins, MD Lombardi Cancer Research Center
  More Information

Additional Information:
No publications provided

Responsible Party: John Marshall, MD, Georgetown University Medical Center
ClinicalTrials.gov Identifier: NCT00004030     History of Changes
Other Study ID Numbers: CDR0000065641, P30CA051008, GUMC-96007, VX-95-853-001, VX-GUMC-96007, NCI-V97-1275
Study First Received: December 10, 1999
Last Updated: March 22, 2011
Health Authority: United States: Federal Government

Keywords provided by Georgetown University:
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Doxorubicin
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 20, 2014