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

Launched by UNIVERSITY OF SOUTHERN CALIFORNIA · Sep 9, 2005

Keywords

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Gender

ALL

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