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

NHS Trust

Status and phase

Completed

Phase 3

Conditions

Primary Peritoneal Cavity Cancer

Fallopian Tube Cancer

Ovarian Cancer

Treatments

Drug: carboplatin

Study type

Interventional

Funder types

Other

Identifiers

NCT00098878

ISRCTN47645935 (Registry Identifier)

SCOTTISH-SCOTROC-4

EU-20402

CDR0000396778 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,300 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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