Trials / Completed
CompletedNCT00032162
Liposomal Doxorubicin and Carboplatin in Treating Patients With Gynecologic Cancer
Phase I/II Trial, Dose Finding Combination Chemotherapy With PegLiposomal Doxorubicin (PLD) And Carboplatin In Patients With Gynecologic Tumors
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 63 (actual)
- Sponsor
- AGO Study Group · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combining liposomal doxorubicin with carboplatin in treating patients who have gynecologic cancer.
Detailed description
OBJECTIVES: * Determine the maximum tolerated dose of doxorubicin HCl liposome when administered with carboplatin in patients with gynecological tumors. * Determine the dose-limiting toxicity of this regimen in these patients. * Determine the kind, frequency, severity, and duration of adverse events in patients treated with this regimen. OUTLINE: This is a multicenter, dose-escalation study of doxorubicin HCl liposome. Patients receive doxorubicin HCl liposome IV over 60 minutes followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 28 days for 6 courses. Cohorts of 3-6 patients receive escalating doses of doxorubicin HCl liposome until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are accrued and treated at the MTD as above. Patients are followed at 4-6 weeks and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 12-24 patients will be accrued for this study within 1 year.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | carboplatin | AUC 6 q4w |
| DRUG | pegylated liposomal doxorubicin hydrochloride | 20/30/40 mg/qm q4w Dose finding study |
Timeline
- Start date
- 2001-08-01
- Primary completion
- 2005-05-01
- First posted
- 2003-01-27
- Last updated
- 2012-05-31
Locations
19 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT00032162. Inclusion in this directory is not an endorsement.