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

Phase 1
18 Years
Not Enrolling
Cancer, Carcinoma

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Trial Information

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

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

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

Type of Study:


Study Design:

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

Outcome Measure:

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

Principal Investigator

Syma Iqbal, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

U.S.C./Norris Comprehensive Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

December 2000

Completion Date:

May 2006

Related Keywords:

  • Cancer
  • Carcinoma
  • Phase 1
  • Phase I
  • Phase one
  • Solid tumor
  • Carcinoma



U.S.C./Norris Comprehensive Cancer Center Los Angeles, California  90033