Cancer, Carcinoma
Conditions
Keywords
Phase 1, Phase I, Phase one, Solid tumor
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.
Interventions
DRUGliposomal doxorubicin and docetaxel
Sponsors
Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
University of Southern California
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
| To establish the toxicity profile of this combination | — |
Countries
United States
Outcome results
None listed