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
18 Years
N/A
Female
Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer
Trial Information
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
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Progression-free survival
Safety Issue:
No
Principal Investigator
Stanley B. Kaye, MD, FRCP
Investigator Role:
Study Chair
Investigator Affiliation:
Royal Marsden NHS Foundation Trust
Authority:
United States: Federal Government
Study ID:
CDR0000396778
NCT ID:
NCT00098878
Start Date:
March 2004
Completion Date:
Related Keywords:
- Fallopian Tube Cancer
- Ovarian Cancer
- Peritoneal Cavity Cancer
- stage I ovarian epithelial cancer
- stage II ovarian epithelial cancer
- stage III ovarian epithelial cancer
- stage IV ovarian epithelial cancer
- fallopian tube cancer
- peritoneal cavity cancer
- Ovarian Neoplasms
- Peritoneal Neoplasms
- Fallopian Tube Neoplasms
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