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

NCT ID: NCT00006267

Last Updated: 2013-07-09

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients who have recurrent or metastatic ovarian epithelial or primary peritoneal cancer.

Detailed Description

OBJECTIVES:

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

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.

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

Conditions

Ovarian Cancer; Primary Peritoneal Cavity Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

rubitecan

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

PATIENT CHARACTERISTICS:

Age:

• Not specified

Performance status:

• GOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

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

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

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Gynecologic Oncology Group

NETWORK

Sponsor Role: lead

Principal Investigators

Edward C. Grendys, MD

Role: STUDY_CHAIR

Robert H. Lurie Cancer Center

Other Identifiers

GOG-0186B

Identifier Type: -

Identifier Source: secondary_id

CDR0000068210

Identifier Type: -

Identifier Source: org_study_id