Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Related Information
Registry Information

Alternate Title

Comparison of Combination Chemotherapy Regimens in Treating Newly Diagnosed Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Closed 18 to 75 Other CAN-NCIC-OV16 EORTC-55012, GEICO-0101, NCT00028743, OV16

Objectives

1. Compare the efficacy of cisplatin and topotecan followed by paclitaxel and carboplatin vs paclitaxel and carboplatin only, in terms of time to disease progression, in patients with newly diagnosed stage IIB-IV ovarian epithelial, primary peritoneal, or fallopian tube cancer.
2. Compare the overall survival of patients treated with these regimens.
3. Compare the clinical objective response rates in patients with measurable disease at baseline treated with these regimens.
4. Compare the toxic effects of these regimens in these patients.
5. Compare the CA 125 normalization rates in patients treated with these regimens.
6. Compare the quality of life of patients treated with these regimens.

Entry Criteria

Disease Characteristics:

• Histologically confirmed stage IIB-IV ovarian epithelial, primary peritoneal, or fallopian tube cancer
  • No borderline ovarian tumors
  • Residual disease allowed



• Fine needle aspiration showing an adenocarcinoma is allowed instead of open or true-cut biopsy if the following are true:
  • Presence of pelvic mass

    AND

  • Omental cake or other metastasis larger than 2 cm in the upper abdomen unless proven stage IV disease

    AND

  • Serum CA 125/carcinoembryonic antigen ratio at least 25 (if less than 25, a barium enema or colonoscopy and gastroscopy or radiological examination of the stomach should be negative for primary tumor within 6 weeks of study)

    AND

  • Normal mammography within 6 weeks of study

Prior/Concurrent Therapy:

Biologic therapy:

• No concurrent biological response modifiers or immunotherapy
• No concurrent prophylactic colony-stimulating factors (CSFs)
  • Concurrent therapeutic CSFs allowed

Chemotherapy:

• No prior chemotherapy for ovarian cancer
• No other concurrent cytotoxic agents

Endocrine therapy:

• No concurrent anticancer hormonal therapy

Radiotherapy:

• No prior radiotherapy for ovarian cancer

Surgery:

• No more than 6 weeks since prior planned pre-chemotherapy surgery for ovarian cancer
• Planned interval debulking allowed
• Concurrent second-look surgery allowed

Other:

• No prior non-surgical therapy for ovarian cancer
• No other concurrent investigational drug therapy
• No other concurrent anticancer treatment
• Concurrent enrollment on CAN-NCIC-OV13/EORTC 55971 allowed

Patient Characteristics:

Age:

• 18 to 75

Performance status:

• ECOG 0-1

Life expectancy:

• At least 12 weeks

Hematopoietic:

• Granulocyte count at least 2,000/mm³
• Platelet count at least 150,000/mm³

Hepatic:

• Not specified

Renal:

• Creatinine no greater than upper limit of normal

Cardiovascular:

• No clinically relevant atrial or ventricular arrhythmias
• No myocardial infarction (MI) within the past 6 months (pretreatment ECG as only evidence of MI allowed)
• No history of second- or third-degree heart blocks unless pacemaker implanted
• History of first-degree heart block allowed

Other:

• Not pregnant or nursing
• Fertile patients must use effective contraception
• No complete bowel obstruction
• No prior allergic reaction to drugs containing Cremophor EL or compounds chemically related to study drugs
• No condition that would preclude high-volume saline diuresis
• No significant neurologic or psychiatric disorder that would preclude study compliance
• No active uncontrolled infection
• No neuropathy greater than grade 1
• No pre-existing hearing loss greater than grade 1
• No other concurrent serious illness or medical condition that would preclude study participation
• No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix

Expected Enrollment

A total of 800 patients (400 per treatment arm) will be accrued for this study within 2 years.

Outline

This is a randomized, multicenter study. Patients are stratified according to participating center, age (65 years and under vs over 65 years), and pre-randomization surgery (no debulking vs debulking with macroscopic residual disease less than 1 cm vs debulking with macroscopic residual disease 1 cm or greater vs debulking with no macroscopic residual disease). Patients are randomized to one of two treatment arms.

• Arm I: Patients receive cisplatin IV over 60 minutes on day 1 and topotecan IV over 30 minutes on days 1-5 of courses 1-4 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 of courses 5-8.



• Arm II: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 of courses 1-8.

In both arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Planned interval debulking surgery should occur after course 3 or 4.

Quality of life is assessed at baseline; on day 1 of courses 3, 5, and 7; at the end of the last course; and at 3 and 6 months after study treatment completion.

Patients are followed every 3 months for 3 years, every 6 months for 2 years, and then annually thereafter.

Hoskins PJ, Vergote I, Stuart G, et al.: A phase III trial of cisplatin plus topotecan followed by paclitaxel plus carboplatin versus standard carboplatin plus paclitaxel as first-line chemotherapy in women with newly diagnosed advanced epithelial ovarian cancer (EOC) (OV.16). A Gynecologic Cancer Intergroup Study of the NCIC CTG, EORTC GCG, and GEICO. [Abstract] J Clin Oncol 26 (Suppl 15): A-LBA5505, 2008.

Trial Contact Information

Trial Lead Organizations

NCIC-Clinical Trials Group

Paul Hoskins, MD, Protocol chair		Ph: 604-877-6000 ext. 2365; 800-663-3333

European Organization for Research and Treatment of Cancer

Ignace Vergote, MD, PhD, Study coordinator		Ph: 31-16-344-635

Related Information

PDQ® clinical trial EORTC-55971

Registry Information
Official Title		A Phase III Study of Cisplatin Plus Topotecan Followed by Paclitaxel Plus Carboplatin Versus Paclitaxel Plus Carboplatin as First Line Chemotherapy in Women with Newly Diagnosed Advanced Epithelial Ovarian Cancer
Trial Start Date		2001-08-31
Registered in ClinicalTrials.gov		NCT00028743
Date Submitted to PDQ		2001-10-30
Information Last Verified		2005-11-02

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