Clinical trial NCT00183742: Trial of Liposomal Doxorubicin (Doxil) and Weekly Docetaxel (Taxotere)
Official title: Phase I Trial of Liposomal Doxorubicin (Doxil) and Weekly Docetaxel (Taxotere)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Carcinoma
Keywords: Phase 1
Phase I
Phase one
Solid tumor
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
First posted: 2005-09-16
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
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
measure: To establish the toxicity profile of this combination
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: U.S.C./Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: U.S.C./Norris Comprehensive Cancer Center
name: Syma Iqbal, M.D.
role: PRINCIPAL_INVESTIGATOR
References: