S9912 Combination Chemo in Stage III Ovarian Cancer,

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy work in 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 II trial to study the effectiveness of combining paclitaxel, cisplatin, and liposomal doxorubicin in treating women who have undergone surgery for stage III ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.

Detailed Description
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OBJECTIVES: Determine the efficacy of intraperitoneal (IP) cisplatin, IP and IV paclitaxel, and IV doxorubicin HCl liposome, in terms of progression-free survival and overall survival, in patients with optimally debulked stage III ovarian epithelial, fallopian tube, or primary peritoneal cancer. Determine the feasibility of and toxic effects associated with this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive paclitaxel IV over 3 hours on day 1, intraperitoneal (IP) cisplatin over 30-60 minutes on day 2, IP paclitaxel over 30-60 minutes on day 8, and doxorubicin HCl liposome IV over 1 hour on day 8. Patients not able to tolerate IP infusion receive paclitaxel IV and cisplatin IV on day 1 only. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 2 years and then annually thereafter. PROJECTED ACCRUAL: A total of 62 patients will be accrued for this study within 4 years.

Official Title
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Phase II Evaluation of Intravenous Paclitaxel, Intraperitoneal Cisplatin, Intravenous Liposomal Doxorubicin and Intraperitoneal Paclitaxel in Women With Optimally-Debulked Stage III Epithelial Ovarian Cancer

Conditions
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Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer

Intervention / Treatment
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* Drug: cisplatin
* Drug: liposomal doxorubicin
* Drug: paclitaxel


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed stage III ovarian epithelial, fallopian tube, or primary peritoneal carcinoma Tumor involves one or both ovaries with microscopically confirmed peritoneal metastasis outside the pelvis and/or regional lymph node metastasis No tumors of borderline or low malignant potential only Mixed Mullerian tumors allowed Must have optimal disease defined as no residual lesions after resection or residual disease such that no single lesion measures greater than 1 cm in diameter Must have undergone staging exploratory laparotomy with tumor debulking within the past 70 days PATIENT CHARACTERISTICS: Age: Not specified Performance status: SWOG 0-1 Life expectancy: Not specified Hematopoietic: Granulocyte count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic: Bilirubin ≤ 2 times upper limit of normal (ULN) SGOT or SGPT ≤ 2 times ULN Renal: Creatinine clearance ≥ 50 mL/min Cardiovascular: No congestive heart failure No cardiac arrhythmia No myocardial infarction or unstable angina within the past 6 months Patients with a history of myocardial disease must not have ischemia or pathologic arrhythmias and must have an ejection fraction > 50% by MUGA Other: Not pregnant or nursing Fertile patients must use effective contraception No active or uncontrolled infection No concurrent fever No grade 2 or greater sensory neuropathy No severe gastrointestinal symptoms (i.e., partial obstruction) and/or bleeding, diarrhea, or abdominal tenderness suggestive of peritoneal irritation or infection No erythema or tenderness of abdominal incision or port site suggestive of underlying infection No other malignancy within the past five years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy for ovarian cancer Chemotherapy: No prior chemotherapy for ovarian cancer Endocrine therapy: Not specified Radiotherapy: No prior pelvic radiotherapy for ovarian cancer Surgery: See Disease Characteristics Recovered from all reversible surgery-related toxic effects Other: No other concurrent antitumor treatment No concurrent antibiotics for infection of undetermined etiology
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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paclitaxel/cisplatin/Liposomal Doxorubicin<br>paclitaxel, cisplatin and liposomal doxorubicin | Drug: cisplatin<br> <br> * Other names: platinol;Drug: liposomal doxorubicin<br> <br> * Other names: doxil;Drug: paclitaxel<br> <br> * Other names: taxol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival | From date of registration to date of progression (as defined per RECIST), symptomatic deterioration or death due to any cause. | Once a month for 6 months, then every 6 months for up to 2 years, then annually thereafter. | 
| Overall Survival | from date of registration to date of death due to any cause. Patients last known to be alive wer censored at date of last contact | Weekly for 6 weeks, then every 6 months for 2 years, then annually thereafter. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Only adverse events that are possibly, probably or definitely related to study drug are reported. | Weekly during 6 weeks of protocol treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage III ovarian epithelial cancer, peritoneal cavity cancer, fallopian tube cancer