Overview

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

Status:
Withdrawn
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Gynecologic Oncology Group
Collaborator:
National Cancer Institute (NCI)
Treatments:
Rubitecan
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

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