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Phase III Multicenter Study in Epithelial Ovarian Carcinoma FIGO Stage IIB-IV Comparing Treatment With Paclitaxel and Carboplatin to Paclitaxel and Carboplatin Sequentially Followed by Topotecan


Phase 3
18 Years
N/A
Open (Enrolling)
Female
Fallopian Tube Cancer, Ovarian Cancer

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Trial Information

Phase III Multicenter Study in Epithelial Ovarian Carcinoma FIGO Stage IIB-IV Comparing Treatment With Paclitaxel and Carboplatin to Paclitaxel and Carboplatin Sequentially Followed by Topotecan


OBJECTIVES: I. Compare survival of patients with stage IIB, III, or IV ovarian epithelial
carcinoma after receiving treatment with paclitaxel and carboplatin with or without
topotecan. II. Compare progression-free survival of these patients after receiving these
treatment regimens. III. Compare the response rate and response duration in these patients
treated with these regimens. IV. Determine the toxic effects of the combination of
paclitaxel, carboplatin, and topotecan in these patients. V. Compare the toxic effects of
these treatment regimens in these patients. VI. Compare quality of life of these patients
treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center and stage (stage IIB and stage III optimally debulked to no greater
than 1 cm residual tumor vs stage IV regardless of residual tumor or residual tumor greater
than 1 cm). Patients are randomized to one of two treatment arms. Arm I: Patients receive
paclitaxel IV over 3 hours and carboplatin IV over 0.5-1 hour on day 1 and topotecan IV over
0.5 hour on days 1-5. Treatment repeats every 21 days for 6 courses (topotecan is
administered for 4 courses only). Arm II: Patients receive paclitaxel and carboplatin as in
arm I. Treatment repeats every 21 days for 6 courses. Quality of life is assessed before
courses 1, 3, and 5 and at 3 weeks and 3 months after completion of treatment in both
treatment arms; before courses 1 and 3 of topotecan in arm I; and at 6 months after
completion of treatment in arm II. Patients are followed every 3 months for 2 years, every 6
months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 914 patients (457 per treatment arm) will be accrued for this
study over 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed stage IIB, III, or IV ovarian epithelial
carcinoma, fallopian tube, or extraovarian papillary serous carcinoma extending to the
ovary No mixed epithelial/non-epithelial tumors (e.g., mixed Mullerian tumors) No tumors
of low malignant potential (e.g., borderline tumors) No symptomatic brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 OR Karnofsky
70-100% Life expectancy: More than 12 weeks Hematopoietic: Absolute neutrophil count at
least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5
times the upper limit of normal (ULN) Alkaline phosphatase no greater than 3 times ULN
Renal: Creatinine no greater than 1.25 times ULN Estimated glomerular filtration rate at
least 60 mL/min Cardiovascular: No history of congestive heart failure (even if medically
controlled) No New York Heart Association class III or IV heart disease No myocardial
infarction within the past 6 months No history of atrial or ventricular arrhythmias Other:
No motor or sensory neurologic pathology or symptoms greater than grade 1 No active
infection or other serious medical condition that would preclude study No prior allergy to
drug containing Cremophor EL No dementia or significantly altered mental state that would
preclude informed consent No complete bowel obstruction No other prior malignancy except
curatively treated nonmelanomatous skin cancer or carcinoma in situ of the cervix Not
pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy No concurrent WBC
transfusions Chemotherapy: No prior chemotherapy No other concurrent chemotherapy
Endocrine therapy: No concurrent hormonal therapy Radiotherapy: No prior radiotherapy No
concurrent radiotherapy Surgery: No more than 6 weeks since prior definitive laparotomy
and recovered Other: No other concurrent antineoplastic agents No other concurrent
investigational drugs

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Jacobus Pfisterer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Schleswig-Holstein

Authority:

United States: Federal Government

Study ID:

CDR0000067994

NCT ID:

NCT00006454

Start Date:

December 1999

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • stage II ovarian epithelial cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • fallopian tube cancer
  • Ovarian Neoplasms
  • Fallopian Tube Neoplasms
  • Neoplasms, Glandular and Epithelial

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