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

Ovarian Cancer Clinical Trial

Official title:

A Phase II Evaluation Of 9-Nitro-Camptothecin In The Third-Line Treatment Of Recurrent Ovarian Or Primary Peritoneal Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00006267
• Other study ID #: CDR0000068210
• Secondary ID: GOG-0186B
• Status: Withdrawn
• Phase: Phase 2
• First received: September 11, 2000
• Last updated: July 8, 2013

Study information

• Verified date: May 2004
• Source: Gynecologic Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Cancer
• Peritoneal Neoplasms
• Primary Peritoneal Cavity Cancer

Intervention

Drug:
• rubitecan

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	National Cancer Institute (NCI)