Carboplatin in Treating Patients With Stage IC-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Detailed Description
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.
Study Design
Outcome Measures
Primary Outcome Measures
- Progression-free survival []
Secondary Outcome Measures
- Toxicity []
- Quality of life []
- Clinical overall response rate and CA125 response []
- Overall survival []
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
-
Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cancer*
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Stage IC-IV disease
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Peritoneal carcinomatosis* (ovarian-type) must not be a mucin-secreting tumor
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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.
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If biospy is not available, cytology showing an adenocarcinoma is allowed provided the following criteria is met:
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Patient has a pelvis (ovarian) mass AND all of the following:
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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
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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
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Initial cytoreductive laparotomy or biopsy required within the past 8 weeks
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Cytoreductive surgery may or may not have been successful during staging laparotomy
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No mixed mesodermal tumors
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No borderline ovarian tumors or tumors termed "possibly malignant"
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No adenocarcinoma of unknown origin, if histologically confirmed to be a mucin-secreting tumor
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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
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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
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No congestive heart failure
Other
-
Not pregnant or nursing
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Fertile patients must use effective contraception
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No symptomatic peripheral neuropathy ≥ grade 2
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No uncontrolled infection
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No other severe and/or uncontrolled medical condition
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sydney Heamatology and Oncology Clinics | Hornsby | New South Wales | Australia | 2077 |
| 2 | Lismore Base Hospital | Lismore | New South Wales | Australia | 2480 |
| 3 | Institute of Oncology at Prince of Wales Hospital | Randwick | New South Wales | Australia | 2031 |
| 4 | Royal North Shore Hospital | St. Leonards | New South Wales | Australia | 2065 |
| 5 | Sydney Cancer Centre at Royal Prince Alfred Hospital | Sydney | New South Wales | Australia | 2050 |
| 6 | Tamworth Base Hospital | Tamworth | New South Wales | Australia | 2340 |
| 7 | Manning Base Hospital | Taree | New South Wales | Australia | 2430 |
| 8 | Newcastle Mater Misericordiae Hospital | Waratah | New South Wales | Australia | 2298 |
| 9 | Westmead Institute for Cancer Research at Westmead Hospital | Wentworthville | New South Wales | Australia | 2145 |
| 10 | Royal Brisbane and Women's Hospital | Brisbane | Queensland | Australia | 4029 |
| 11 | Townsville Hospital | Douglas | Queensland | Australia | 4814 |
| 12 | Mater Adult Hospital | South Brisbane | Queensland | Australia | 4101 |
| 13 | Flinders Medical Centre | Bedford Park | South Australia | Australia | 5042 |
| 14 | Royal Hobart Hospital | Hobart | Tasmania | Australia | 7000 |
| 15 | Ballarat Oncology and Haematology Services | Ballarat | Victoria | Australia | 3350 |
| 16 | Box Hill Hospital | Box Hill | Victoria | Australia | 3128 |
| 17 | Royal Women's Hospital | Carlton | Victoria | Australia | 3053 |
| 18 | Monash Medical Center - Clayton Campus | Clayton | Victoria | Australia | 3168 |
| 19 | Frankston Hospital | Frankston | Victoria | Australia | 3199 |
| 20 | Mercy Hospital for Women | Heidelberg | Victoria | Australia | 3084 |
| 21 | Murray Valley Private Hospital and Cancer Treatment Centre | Wodonga | Victoria | Australia | 3690 |
| 22 | Auckland City Hospital | Auckland | New Zealand | 1 | |
| 23 | Christchurch Hospital | Christchurch | New Zealand | 1 | |
| 24 | Waikato Hospital | Hamilton | New Zealand | 2020 | |
| 25 | Wellington Cancer Centre | Wellington | New Zealand | 6039 | |
| 26 | Furness General Hospital | Barrow in Furness | England | United Kingdom | LA14 4LF |
| 27 | Royal United Hospital | Bath | England | United Kingdom | BA1 3NG |
| 28 | Birmingham Heartlands Hospital | Birmingham | England | United Kingdom | B9 5SS |
| 29 | Royal Blackburn Hospital | Blackburn | England | United Kingdom | BB2 3HH |
| 30 | Blackpool Victoria Hospital | Blackpool | England | United Kingdom | FY3 8NR |
| 31 | Bradford Royal Infirmary | Bradford | England | United Kingdom | BD9 6RJ |
| 32 | Sussex Cancer Centre at Royal Sussex County Hospital | Brighton | England | United Kingdom | BN2 5BE |
| 33 | Bristol Haematology and Oncology Centre | Bristol | England | United Kingdom | BS2 8ED |
| 34 | Broomfield Hospital | Broomfield | England | United Kingdom | CM1 7ET |
| 35 | Queen's Hospital | Burton-upon-Trent | England | United Kingdom | DE13 0RB |
| 36 | Cheltenham General Hospital | Cheltenham | England | United Kingdom | GL53 7AN |
| 37 | Essex County Hospital | Colchester | England | United Kingdom | C03 3NB |
| 38 | Walsgrave Hospital | Coventry | England | United Kingdom | CV2 2DX |
| 39 | Derbyshire Royal Infirmary | Derby | England | United Kingdom | DE1 2QY |
| 40 | Dorset County Hospital | Dorchester | England | United Kingdom | DT1 2JY |
| 41 | Russells Hall Hospital | Dudley | England | United Kingdom | DY1 2HQ |
| 42 | Gloucestershire Royal Hospital | Gloucester | England | United Kingdom | GL1 3NN |
| 43 | Hereford Hospitals NHS Trust | Hereford | England | United Kingdom | HR1 2ER |
| 44 | Huddersfield Royal Infirmary | Huddersfield, West Yorks | England | United Kingdom | HD3 3EA |
| 45 | Ipswich Hospital | Ipswich | England | United Kingdom | IP4 5PD |
| 46 | Airedale General Hospital | Keighley | England | United Kingdom | BD20 6TD |
| 47 | Royal Lancaster Infirmary | Lancaster | England | United Kingdom | LA1 4RP |
| 48 | Leeds Cancer Centre at St. James's University Hospital | Leeds | England | United Kingdom | LS9 7TF |
| 49 | Leicester Royal Infirmary | Leicester | England | United Kingdom | LE1 5WW |
| 50 | Liverpool Women's Hospital | Liverpool | England | United Kingdom | LV8 7SS |
| 51 | Saint Bartholomew's Hospital | London | England | United Kingdom | EC1A 7BE |
| 52 | University College of London Hospitals | London | England | United Kingdom | NW1 2PG |
| 53 | Guy's Hospital | London | England | United Kingdom | SE1 9RT |
| 54 | St. Georges, University of London | London | England | United Kingdom | SW17 0QT |
| 55 | Hammersmith Hospital | London | England | United Kingdom | W12 OHS |
| 56 | Mid Kent Oncology Centre at Maidstone Hospital | Maidstone | England | United Kingdom | ME16 9QQ |
| 57 | Christie Hospital | Manchester | England | United Kingdom | M20 4BX |
| 58 | Queen Elizabeth The Queen Mother Hospital | Margate | England | United Kingdom | CT9 4AN |
| 59 | Clatterbridge Centre for Oncology | Merseyside | England | United Kingdom | CH63 4JY |
| 60 | Northampton General Hospital NHS Trust | Northampton | England | United Kingdom | NN1 5BD |
| 61 | Mount Vernon Cancer Centre at Mount Vernon Hospital | Northwood | England | United Kingdom | HA6 2RN |
| 62 | Kings Mill Hospital | Nottinghamshire | England | United Kingdom | NG17 4JL |
| 63 | Nottingham City Hospital NHS Trust | Nottingham | England | United Kingdom | NG5 1PB |
| 64 | George Eliot Hospital | Nuneaton | England | United Kingdom | CV10 7DJ |
| 65 | Whiston Hospital | Prescot Merseyside | England | United Kingdom | L35 5DR |
| 66 | Rosemere Cancer Centre at Royal Preston Hospital | Preston | England | United Kingdom | PR2 9HT |
| 67 | Alexandra Healthcare NHS | Redditch, Worcestershire | England | United Kingdom | B98 7UB |
| 68 | Cancer Research Centre at Weston Park Hospital | Sheffield | England | United Kingdom | S1O 2SJ |
| 69 | Wexham Park Hospital | Slough, Berkshire | England | United Kingdom | SL2 4HL |
| 70 | Royal Marsden - Surrey | Sutton | England | United Kingdom | SM2 5PT |
| 71 | Taunton and Somerset Hospital | Taunton Somerset | England | United Kingdom | TA1 5DA |
| 72 | South Warwickshire Hospital | Warwick, Warwickshire | England | United Kingdom | CV34 5BJ |
| 73 | Southend University Hospital NHS Foundation Trust | Westcliff-On-Sea | England | United Kingdom | SS0 0RY |
| 74 | Weston General Hospital | Weston-super-Mare | England | United Kingdom | BS23 4TQ |
| 75 | Worcester Royal Hospital | Worcester | England | United Kingdom | WR5 1DD |
| 76 | Worthing Hospital | Worthing | England | United Kingdom | BN11 2DH |
| 77 | Yeovil District Hospital | Yeovil - Somerset | England | United Kingdom | BA21 4AT |
| 78 | Centre for Cancer Research and Cell Biology at Queen's University Belfast | Belfast | Northern Ireland | United Kingdom | BT9 7BL |
| 79 | Aberdeen Royal Infirmary | Aberdeen | Scotland | United Kingdom | AB25 2ZN |
| 80 | Dumfries & Galloway Royal Infirmary | Dumfries | Scotland | United Kingdom | DG1 4AP |
| 81 | Ninewells Hospital | Dundee | Scotland | United Kingdom | DD1 9SY |
| 82 | Edinburgh Cancer Centre at Western General Hospital | Edinburgh | Scotland | United Kingdom | EH4 2XR |
| 83 | Gartnavel General Hospital | Glasgow | Scotland | United Kingdom | G12 0YN |
| 84 | Raigmore Hospital | Inverness | Scotland | United Kingdom | 1V2 3UJ |
| 85 | Ysbyty Gwynedd | Bangor | Wales | United Kingdom | LL57 2PW |
| 86 | Velindre Cancer Center at Velindre Hospital | Cardiff | Wales | United Kingdom | CF4 7XL |
| 87 | West Wales General Hospital | Carmarthen | Wales | United Kingdom | SA31 2AF |
| 88 | South West Wales Cancer Institute | Swansea | Wales | United Kingdom | SA2 8QA |
Sponsors and Collaborators
- NHS Greater Glasgow and Clyde
Investigators
- Study Chair: Stanley B. Kaye, MD, FRCP, Royal Marsden NHS Foundation Trust
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SCOTTISH-SCOTROC-4
- CDR0000396778
- EU-20402
- ISRCTN47645935