Trial of Liposomal Doxorubicin (Doxil) and Weekly Docetaxel (Taxotere)

NCT ID: NCT00183742

Last Updated: 2014-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-12-31
• Study Completion Date: 2006-05-31

Brief Summary

This study is for patients with advanced cancer that has failed treatment with conventional therapy or for which no standard treatment exists. The purpose of this study is to determine the highest dose that can be given of 2 chemotherapy drugs, docetaxel (also called Taxotere) and liposomal doxorubicin (also called Doxil), when given together and to determine the side effects of this combination. Both Taxotere and Doxil are chemotherapy drugs that can decrease the size of several different tumors. Taxotere is approved by the Food and Drug Administration (FDA) for the treatment of breast and lung cancers, and Doxil is approved for the treatment of ovarian cancer.

Conditions

Cancer; Carcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

liposomal doxorubicin and docetaxel

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Histological proof of advanced or recurrent solid tumor which has failed prior therapy, or for which no effective therapy is available.
• Ovarian cancer patients (or primary peritoneal carcinoma) whose only manifestation of disease is an elevated cancer antigen (CA) 125 of > 100 are eligible.
• SWOG performance status 0-2.
• Absolute granulocyte count (AGC) greater than or equal to 1.5; platelets greater than or equal to 100,000.
• Total bilirubin less than or equal to the upper limit of normal (ULN).
• Transaminases (SGOT and/or SGPT) may be up to 2.5 x institutional upper limit of normal (ULN) if alkaline phosphatase is <= ULN, or alkaline phosphatase may be up to 4 x ULN if transaminases are <= ULN. However, patients who have both transaminase elevation > 1.5 x ULN and alkaline phosphatase > 2.5 x ULN are not eligible for this study (due to decreased clearance of docetaxel and increased risk of toxicity).
• Age greater than or equal to 18 years.
• Fully recovered from acute toxicities from chemotherapy, radiation, or surgery.
• Negative serum pregnancy test, if patient is female, still fertile, and sexually active.

Exclusion Criteria

• Prior treatment with Doxil or weekly docetaxel. Prior docetaxel administered every 3 weeks is allowed.
• Evidence of moderate peripheral neuropathy greater than or equal to grade 2.
• Medical, social, or psychological factors interfering with compliance.
• Known history of cardiac disease (congestive heart failure, coronary artery disease) that would preclude treatment with Doxil in the opinion of the investigator.
• Cardiac ejection fraction < 50%
• Pregnancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA

INDUSTRY

Sponsor Role: collaborator

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Syma Iqbal, M.D.

Role: PRINCIPAL_INVESTIGATOR

U.S.C./Norris Comprehensive Cancer Center

Locations

U.S.C./Norris Comprehensive Cancer Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

0C-00-6

Identifier Type: -

Identifier Source: org_study_id