Clinical trial NCT00098878: Carboplatin in Treating Patients With Stage IC-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fallopian Tube Cancer
Ovarian Cancer
Primary Peritoneal Cavity Cancer
Keywords: 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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2004-12-09
Enrollment: 1300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Progression-free survival
Secondary outcomes:
measure: Toxicity
measure: Quality of life
measure: Clinical overall response rate and CA125 response
measure: Overall survival
Other outcomes:
Locations:
city: Hornsby
country: Australia
facility: Sydney Heamatology and Oncology Clinics
state: New South Wales
city: Lismore
country: Australia
facility: Lismore Base Hospital
state: New South Wales
city: Randwick
country: Australia
facility: Institute of Oncology at Prince of Wales Hospital
state: New South Wales
city: St. Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Sydney Cancer Centre at Royal Prince Alfred Hospital
state: New South Wales
city: Tamworth
country: Australia
facility: Tamworth Base Hospital
state: New South Wales
city: Taree
country: Australia
facility: Manning Base Hospital
state: New South Wales
city: Waratah
country: Australia
facility: Newcastle Mater Misericordiae Hospital
state: New South Wales
city: Wentworthville
country: Australia
facility: Westmead Institute for Cancer Research at Westmead Hospital
state: New South Wales
city: Brisbane
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: Douglas
country: Australia
facility: Townsville Hospital
state: Queensland
city: South Brisbane
country: Australia
facility: Mater Adult Hospital
state: Queensland
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Hobart
country: Australia
facility: Royal Hobart Hospital
state: Tasmania
city: Ballarat
country: Australia
facility: Ballarat Oncology and Haematology Services
state: Victoria
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Carlton
country: Australia
facility: Royal Women's Hospital
state: Victoria
city: Clayton
country: Australia
facility: Monash Medical Center - Clayton Campus
state: Victoria
city: Frankston
country: Australia
facility: Frankston Hospital
state: Victoria
city: Heidelberg
country: Australia
facility: Mercy Hospital for Women
state: Victoria
city: Wodonga
country: Australia
facility: Murray Valley Private Hospital and Cancer Treatment Centre
state: Victoria
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Wellington
country: New Zealand
facility: Wellington Cancer Centre
city: Barrow in Furness
country: United Kingdom
facility: Furness General Hospital
state: England
city: Bath
country: United Kingdom
facility: Royal United Hospital
state: England
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital
state: England
city: Blackburn
country: United Kingdom
facility: Royal Blackburn Hospital
state: England
city: Blackpool
country: United Kingdom
facility: Blackpool Victoria Hospital
state: England
city: Bradford
country: United Kingdom
facility: Bradford Royal Infirmary
state: England
city: Brighton
country: United Kingdom
facility: Sussex Cancer Centre at Royal Sussex County Hospital
state: England
city: Bristol
country: United Kingdom
facility: Bristol Haematology and Oncology Centre
state: England
city: Broomfield
country: United Kingdom
facility: Broomfield Hospital
state: England
city: Burton-upon-Trent
country: United Kingdom
facility: Queen's Hospital
state: England
city: Cheltenham
country: United Kingdom
facility: Cheltenham General Hospital
state: England
city: Colchester
country: United Kingdom
facility: Essex County Hospital
state: England
city: Coventry
country: United Kingdom
facility: Walsgrave Hospital
state: England
city: Derby
country: United Kingdom
facility: Derbyshire Royal Infirmary
state: England
city: Dorchester
country: United Kingdom
facility: Dorset County Hospital
state: England
city: Dudley
country: United Kingdom
facility: Russells Hall Hospital
state: England
city: Gloucester
country: United Kingdom
facility: Gloucestershire Royal Hospital
state: England
city: Hereford
country: United Kingdom
facility: Hereford Hospitals NHS Trust
state: England
city: Huddersfield, West Yorks
country: United Kingdom
facility: Huddersfield Royal Infirmary
state: England
city: Ipswich
country: United Kingdom
facility: Ipswich Hospital
state: England
city: Keighley
country: United Kingdom
facility: Airedale General Hospital
state: England
city: Lancaster
country: United Kingdom
facility: Royal Lancaster Infirmary
state: England
city: Leeds
country: United Kingdom
facility: Leeds Cancer Centre at St. James's University Hospital
state: England
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
state: England
city: Liverpool
country: United Kingdom
facility: Liverpool Women's Hospital
state: England
city: London
country: United Kingdom
facility: Saint Bartholomew's Hospital
state: England
city: London
country: United Kingdom
facility: University College of London Hospitals
state: England
city: London
country: United Kingdom
facility: Guy's Hospital
state: England
city: London
country: United Kingdom
facility: St. Georges, University of London
state: England
city: London
country: United Kingdom
facility: Hammersmith Hospital
state: England
city: Maidstone
country: United Kingdom
facility: Mid Kent Oncology Centre at Maidstone Hospital
state: England
city: Manchester
country: United Kingdom
facility: Christie Hospital
state: England
city: Margate
country: United Kingdom
facility: Queen Elizabeth The Queen Mother Hospital
state: England
city: Merseyside
country: United Kingdom
facility: Clatterbridge Centre for Oncology
state: England
city: Northampton
country: United Kingdom
facility: Northampton General Hospital NHS Trust
state: England
city: Northwood
country: United Kingdom
facility: Mount Vernon Cancer Centre at Mount Vernon Hospital
state: England
city: Nottinghamshire
country: United Kingdom
facility: Kings Mill Hospital
state: England
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital NHS Trust
state: England
city: Nuneaton
country: United Kingdom
facility: George Eliot Hospital
state: England
city: Prescot Merseyside
country: United Kingdom
facility: Whiston Hospital
state: England
city: Preston
country: United Kingdom
facility: Rosemere Cancer Centre at Royal Preston Hospital
state: England
city: Redditch, Worcestershire
country: United Kingdom
facility: Alexandra Healthcare NHS
state: England
city: Sheffield
country: United Kingdom
facility: Cancer Research Centre at Weston Park Hospital
state: England
city: Slough, Berkshire
country: United Kingdom
facility: Wexham Park Hospital
state: England
city: Sutton
country: United Kingdom
facility: Royal Marsden - Surrey
state: England
city: Taunton Somerset
country: United Kingdom
facility: Taunton and Somerset Hospital
state: England
city: Warwick, Warwickshire
country: United Kingdom
facility: South Warwickshire Hospital
state: England
city: Westcliff-On-Sea
country: United Kingdom
facility: Southend University Hospital NHS Foundation Trust
state: England
city: Weston-super-Mare
country: United Kingdom
facility: Weston General Hospital
state: England
city: Worcester
country: United Kingdom
facility: Worcester Royal Hospital
state: England
city: Worthing
country: United Kingdom
facility: Worthing Hospital
state: England
city: Yeovil - Somerset
country: United Kingdom
facility: Yeovil District Hospital
state: England
city: Belfast
country: United Kingdom
facility: Centre for Cancer Research and Cell Biology at Queen's University Belfast
state: Northern Ireland
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
state: Scotland
city: Dumfries
country: United Kingdom
facility: Dumfries & Galloway Royal Infirmary
state: Scotland
city: Dundee
country: United Kingdom
facility: Ninewells Hospital
state: Scotland
city: Edinburgh
country: United Kingdom
facility: Edinburgh Cancer Centre at Western General Hospital
state: Scotland
city: Glasgow
country: United Kingdom
facility: Gartnavel General Hospital
state: Scotland
city: Inverness
country: United Kingdom
facility: Raigmore Hospital
state: Scotland
city: Bangor
country: United Kingdom
facility: Ysbyty Gwynedd
state: Wales
city: Cardiff
country: United Kingdom
facility: Velindre Cancer Center at Velindre Hospital
state: Wales
city: Carmarthen
country: United Kingdom
facility: West Wales General Hospital
state: Wales
city: Swansea
country: United Kingdom
facility: South West Wales Cancer Institute
state: Wales
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: Stanley B. Kaye, MD, FRCP
role: STUDY_CHAIR
References: