Liposomal Doxorubicin and Carboplatin in Treating Patients With Gynecologic Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase I/II Trial, Dose Finding Combination Chemotherapy With PegLiposomal Doxorubicin (PLD) And Carboplatin In Patients With Gynecologic Tumors

Conditions
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Cervical Cancer, Endometrial Cancer, Fallopian Tube Cancer, Ovarian Cancer, Sarcoma

Intervention / Treatment
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* Drug: carboplatin
* Drug: pegylated liposomal doxorubicin hydrochloride


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically or cytologically confirmed fallopian tube cancer, Muellerian mixed tumor, endometrial cancer, uterine sarcoma, ovarian cancer with sarcoma parts, or cervical cancer No ovarian epithelial cancer PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 OR Karnofsky 70-100% Life expectancy: At least 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin greater than 10.0 g/dL Hepatic: Bilirubin no greater than 1.25 times upper limit of normal Renal: Glomerular filtration rate at least 60 mL/min Cardiovascular: No atrial or ventricular arrhythmias No congestive heart failure even if stabilized on medication No New York Heart Association class III or IV heart disease No myocardial infarction within the past 6 months Other: No pre-existing sensory or motor neuropathy grade 2 or greater No active infection No other serious medical condition that would preclude study Not pregnant Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy Chemotherapy: No more than 1 prior chemotherapy regimen for the malignancy No other concurrent chemotherapy Endocrine therapy: Prior hormonal therapy within the past 10 days allowed No concurrent hormonal therapy Radiotherapy: At least 6 weeks since prior radiotherapy to no more than 25% of bone marrow Surgery: Not specified Other: At least 30 days since prior experimental agents No other concurrent therapies that would preclude study No concurrent participation in another study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PLD<br>dose finding study of PLD in combination with Carboplatin | Drug: carboplatin<br>* AUC 6 q4w<br>Drug: pegylated liposomal doxorubicin hydrochloride<br>* 20/30/40 mg/qm q4w Dose finding study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DL DLT |  | DLT during first 3 cycles | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage III cervical cancer, recurrent cervical cancer, stage IB cervical cancer, stage IIB cervical cancer, stage IVB cervical cancer, stage IA cervical cancer, stage IIA cervical cancer, stage IVA cervical cancer, stage I endometrial carcinoma, stage II endometrial carcinoma, stage III endometrial carcinoma, stage IV endometrial carcinoma, recurrent endometrial carcinoma, fallopian tube cancer, stage I uterine sarcoma, stage II uterine sarcoma, stage III uterine sarcoma, stage IV uterine sarcoma, recurrent uterine sarcoma, ovarian sarcoma, ovarian carcinosarcoma