Carboplatin in Treating Patients With Stage IC-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This randomized phase III trial is comparing different doses of carboplatin to see how well they work in treating patients with stage IC, stage II, stage III, or stage IV ovarian, fallopian tube, or primary peritoneal cancer.

Detailed Description
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OBJECTIVES: Primary Compare progression-free survival of patients with stage IC-IV ovarian epithelial, fallopian tube, or primary peritoneal cancer treated with flat-dose vs intra-patient dose-escalated carboplatin as first-line chemotherapy. Secondary Compare the toxic effects of these regimens in these patients. Compare the quality of life of patients treated with these regimens. Compare overall clinical response rate and CA 125 response in patients treated with these regimens. Compare overall survival of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive a flat dose of carboplatin on day 1. Arm II: Patients receive intra-patient dose-escalated carboplatin on day 1. In both arms, treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, before each treatment course, and then at 2 months post-chemotherapy. Patients are followed every 2 months for 2 years, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months thereafter. Peer Reviewed and Funded or Endorsed by Cancer Research UK PROJECTED ACCRUAL: A total of 1,300 patients (650 per treatment arm) will be accrued for this study.

Official Title
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SCOTROC 4: A Prospective, Multicentre, Randomised Trial Of Carboplatin Flat Dosing Vs Intrapatient Dose Escalation In First Line Chemotherapy Of Ovarian, Fallopian Tube And Primary Peritoneal Cancers

Conditions
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Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Intervention / Treatment
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* Drug: carboplatin


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cancer* Stage IC-IV disease Peritoneal carcinomatosis* (ovarian-type) must not be a mucin-secreting tumor Stage IC patients must have malignant cells in ascitic fluid or peritoneal washings, tumor on the surface of the ovary, or preoperative capsule rupture NOTE: * Histologic confirmation of a primary source in the ovary is not required. If biospy is not available, cytology showing an adenocarcinoma is allowed provided the following criteria is met: Patient has a pelvis (ovarian) mass AND all of the following: Omental cake or other metastasis is larger than 2 cm in the upper abdomen and/or regional lymph node metastasis irrespective of size OR stage IV disease Serum CA 125/CEA ratio > 25 or barium enema (or colonoscopy) and gastroscopy (or radiological examination of the stomach) are negative for the presence of a primary tumor and normal mammography within 6 weeks prior to study randomization Initial cytoreductive laparotomy or biopsy required within the past 8 weeks Cytoreductive surgery may or may not have been successful during staging laparotomy No mixed mesodermal tumors No borderline ovarian tumors or tumors termed possibly malignant No adenocarcinoma of unknown origin, if histologically confirmed to be a mucin-secreting tumor Considered unsuitable for or unwilling to receive platinum-taxane combination therapy No concurrent endometrial cancer PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-3 Life expectancy Not specified Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic Bilirubin normal AST and ALT ≤ 2.5 times upper limit of normal (ULN) Alkaline phosphatase ≤ 5 times ULN Renal Creatinine clearance ≥ 30 mL/min Obstructive hydronephrosis as a cause of borderline (i.e., creatinine clearance 30-45 mL/min) renal function must be treated before study entry Cardiovascular No hypertension No ischemic heart disease No myocardial infarction within the past 6 months No congestive heart failure Other Not pregnant or nursing Fertile patients must use effective contraception No symptomatic peripheral neuropathy ≥ grade 2 No uncontrolled infection No other severe and/or uncontrolled medical condition No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or basal cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy No other concurrent cytotoxic chemotherapy until progressive disease occurs Endocrine therapy Not specified Radiotherapy No prior radiotherapy Surgery See Disease Characteristics

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: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: carboplatin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity |  |  | 
| Quality of life |  |  | 
| Clinical overall response rate and CA125 response |  |  | 
| Overall survival |  |  | 

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