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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00183742
• Other study ID #: 0C-00-6
• Status: Completed
• Phase: Phase 1
• First received: September 9, 2005
• Last updated: May 20, 2014
• Start date: December 2000
• Est. completion date: May 2006

Study information

• Verified date: May 2014
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: May 2006
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer
• Carcinoma

Intervention

Drug:
• liposomal doxorubicin and docetaxel

Locations

Country	Name	City	State
United States	U.S.C./Norris Comprehensive Cancer Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the maximum tolerated dose (MTD) of liposomal doxorubicin (Doxil) administered every 4 weeks or every 2 weeks in combination with docetaxel (Taxotere) administered on a weekly schedule
Primary	To establish the toxicity profile of this combination