Brief Title
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
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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Progression-free survival
Secondary Outcome
Toxicity
Condition
Fallopian Tube Cancer
Intervention
carboplatin
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
1300
Start Date
March 2004
Completion Date
July 2010
Primary Completion Date
July 2010
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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Stanley B. Kaye, MD, FRCP, ,
Location Countries
Australia
Location Countries
Australia
Administrative Informations
NCT ID
NCT00098878
Organization ID
SCOTTISH-SCOTROC-4
Secondary IDs
CDR0000396778
Study Sponsor
NHS Greater Glasgow and Clyde
Study Sponsor
Stanley B. Kaye, MD, FRCP, Study Chair, Royal Marsden NHS Foundation Trust
Verification Date
July 2009