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NCT00098878

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

Last Updated: 2013-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2010-07-31

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.

Conditions

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Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer

Keywords

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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

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Interventions

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carboplatin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Principal Investigators

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Stanley B. Kaye, MD, FRCP

Role: STUDY_CHAIR

Royal Marsden NHS Foundation Trust

Locations

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Sydney Heamatology and Oncology Clinics

Hornsby, New South Wales, Australia

Site Status

Lismore Base Hospital

Lismore, New South Wales, Australia

Site Status

Institute of Oncology at Prince of Wales Hospital

Randwick, New South Wales, Australia

Site Status

Royal North Shore Hospital

St Leonards, New South Wales, Australia

Site Status

Sydney Cancer Centre at Royal Prince Alfred Hospital

Sydney, New South Wales, Australia

Site Status

Tamworth Base Hospital

Tamworth, New South Wales, Australia

Site Status

Manning Base Hospital

Taree, New South Wales, Australia

Site Status

Newcastle Mater Misericordiae Hospital

Waratah, New South Wales, Australia

Site Status

Westmead Institute for Cancer Research at Westmead Hospital

Wentworthville, New South Wales, Australia

Site Status

Royal Brisbane and Women's Hospital

Brisbane, Queensland, Australia

Site Status

Townsville Hospital

Douglas, Queensland, Australia

Site Status

Mater Adult Hospital

South Brisbane, Queensland, Australia

Site Status

Flinders Medical Centre

Bedford Park, South Australia, Australia

Site Status

Royal Hobart Hospital

Hobart, Tasmania, Australia

Site Status

Ballarat Oncology and Haematology Services

Ballarat, Victoria, Australia

Site Status

Box Hill Hospital

Box Hill, Victoria, Australia

Site Status

Royal Women's Hospital

Carlton, Victoria, Australia

Site Status

Monash Medical Center - Clayton Campus

Clayton, Victoria, Australia

Site Status

Frankston Hospital

Frankston, Victoria, Australia

Site Status

Mercy Hospital for Women

Heidelberg, Victoria, Australia

Site Status

Murray Valley Private Hospital and Cancer Treatment Centre

Wodonga, Victoria, Australia

Site Status

Auckland City Hospital

Auckland, , New Zealand

Site Status

Christchurch Hospital

Christchurch, , New Zealand

Site Status

Waikato Hospital

Hamilton, , New Zealand

Site Status

Wellington Cancer Centre

Wellington, , New Zealand

Site Status

Furness General Hospital

Barrow in Furness, England, United Kingdom

Site Status

Royal United Hospital

Bath, England, United Kingdom

Site Status

Birmingham Heartlands Hospital

Birmingham, England, United Kingdom

Site Status

Royal Blackburn Hospital

Blackburn, England, United Kingdom

Site Status

Blackpool Victoria Hospital

Blackpool, England, United Kingdom

Site Status

Bradford Royal Infirmary

Bradford, England, United Kingdom

Site Status

Sussex Cancer Centre at Royal Sussex County Hospital

Brighton, England, United Kingdom

Site Status

Bristol Haematology and Oncology Centre

Bristol, England, United Kingdom

Site Status

Broomfield Hospital

Broomfield, England, United Kingdom

Site Status

Queen's Hospital

Burton-on-Trent, England, United Kingdom

Site Status

Cheltenham General Hospital

Cheltenham, England, United Kingdom

Site Status

Essex County Hospital

Colchester, England, United Kingdom

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Walsgrave Hospital

Coventry, England, United Kingdom

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Derbyshire Royal Infirmary

Derby, England, United Kingdom

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Dorset County Hospital

Dorchester, England, United Kingdom

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Russells Hall Hospital

Dudley, England, United Kingdom

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Gloucestershire Royal Hospital

Gloucester, England, United Kingdom

Site Status

Hereford Hospitals NHS Trust

Hereford, England, United Kingdom

Site Status

Huddersfield Royal Infirmary

Huddersfield, West Yorks, England, United Kingdom

Site Status

Ipswich Hospital

Ipswich, England, United Kingdom

Site Status

Airedale General Hospital

Keighley, England, United Kingdom

Site Status

Royal Lancaster Infirmary

Lancaster, England, United Kingdom

Site Status

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, United Kingdom

Site Status

Leicester Royal Infirmary

Leicester, England, United Kingdom

Site Status