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

Alternate Title

Nitrocamptothecin in Treating Patients With Recurrent or Metastatic Ovarian Epithelial or Primary Peritoneal Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	Not specified	NCI	GOG-0186B NCT00006267

Objectives

1. Determine the antitumor activity of nitrocamptothecin in patients with recurrent or metastatic ovarian epithelial or primary peritoneal cancer.
2. Determine the nature and degree of toxicity of this regimen in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed recurrent or metastatic ovarian epithelial or primary peritoneal cancer



• Measurable disease
  • Ascites and pleural effusions are not considered measurable
  • Sonography allowed if bidimensionally measurable



• Must not be eligible for higher priority GOG protocol

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• At least but no more than 2 prior chemotherapy regimens containing carboplatin, cisplatin, or another organoplatinum compound combined with paclitaxel
• Second line therapy may include any agents except topoisomerase I inhibitors (i.e., topotecan)
• No prior nitrocamptothecin or topoisomerase I inhibitors
• At least 3 weeks since prior chemotherapy and recovered

Endocrine therapy:

• Not specified

Radiotherapy:

• At least 3 weeks since prior radiotherapy and recovered

Surgery:

• At least 3 weeks since prior surgery and recovered

Other:

• No prior cancer therapy that contraindicates this study

Patient Characteristics:

Age:

• Not specified

Performance status:

• GOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 3,000/mm³
• Platelet count at least 100,000/mm³
• Granulocyte count at least 1,500/mm³

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• SGOT and alkaline phosphatase no greater than 3 times ULN

Renal:

• Creatinine no greater than 2.0 mg/dL

Other:

• No other prior or concurrent invasive malignancy in the past 5 years except nonmelanoma skin cancer
• No active infection

Expected Enrollment

Approximately 19-51 patients will be accrued for this study within 22 months.

Outline

Patients receive oral nitrocamptothecin on days 1-5. Treatment continues every 7 days in the absence of disease progression or unacceptable toxicity.

Patients are followed at 2 weeks, then every 3 months for 2 years, and then every 6 months for 3 years.

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

Edward Grendys, MD, Protocol chair(Contact information may not be current)		Ph: 312-926-7365

Registry Information
Official Title		A Phase II Evaluation Of 9-Nitro-Camptothecin In The Third-Line Treatment Of Recurrent Ovarian Or Primary Peritoneal Cancer
Registered in ClinicalTrials.gov		NCT00006267
Date Submitted to PDQ		2000-08-03
Information Last Verified		2004-05-10
NCI Grant/Contract Number		CA27469

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