- 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
- 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%