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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00183742
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : May 22, 2014
Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
Information provided by (Responsible Party):
University of Southern California

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.

Condition or disease Intervention/treatment Phase
Cancer Carcinoma Drug: liposomal doxorubicin and docetaxel Phase 1

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Study Type : Interventional  (Clinical Trial)
Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Trial of Liposomal Doxorubicin (Doxil) and Weekly Docetaxel (Taxotere)
Study Start Date : December 2000
Actual Primary Completion Date : October 2005
Actual Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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
  2. To establish the toxicity profile of this combination

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00183742

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United States, California
U.S.C./Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
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Principal Investigator: Syma Iqbal, M.D. U.S.C./Norris Comprehensive Cancer Center

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Responsible Party: University of Southern California Identifier: NCT00183742     History of Changes
Other Study ID Numbers: 0C-00-6
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: May 22, 2014
Last Verified: May 2014
Keywords provided by University of Southern California:
Phase 1
Phase I
Phase one
Solid tumor
Additional relevant MeSH terms:
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Liposomal doxorubicin
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors