Phase II Evaluation of Intravenous Paclitaxel, Intraperitoneal Cisplatin, Intravenous Liposomal Doxorubicin and Intraperitoneal Paclitaxel in Women With Optimally-Debulked Stage III Epithelial Ovarian Cancer
cisplatin
+ liposomal doxorubicin
+ paclitaxel
Urogenital Diseases+18
+ Genital Diseases
+ Adnexal Diseases
Treatment Study
Summary
Study start date: September 1, 1999
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.68 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 104 locations
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, United StatesOpen Arizona Cancer Center at University of Arizona Health Sciences Center in Google MapsUniversity of California Davis Cancer Center
Davis, United StatesCity of Hope Comprehensive Cancer Center
Duarte, United StatesSaint Rose Hospital
Hayward, United States