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A Phase II Trial of 72-Hour Continuous IV Infusion of 9-Aminocamptothecin With G-CSF Support in Patients With Advanced Ovarian Cancer Previously Treated With Paclitaxel and Cisplatin


Phase 2
N/A
N/A
Not Enrolling
Female
Ovarian Neoplasms

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Trial Information

A Phase II Trial of 72-Hour Continuous IV Infusion of 9-Aminocamptothecin With G-CSF Support in Patients With Advanced Ovarian Cancer Previously Treated With Paclitaxel and Cisplatin


This is a Phase II study of 9-aminocamptothecin (9-AC), administered as an intravenous
continuous infusion over 72 hours with G-CSF support for patients with advanced refractory
ovarian cancer. The objectives of the present study are to determine the response rate to
9-AC in patients with advanced ovarian cancer who have recurrent disease after paclitaxel-
and cisplatin-based chemotherapy regimens.

Inclusion Criteria


DISEASE CHARACTERISTICS:

Histologically proven, advanced epithelial ovarian cancer.

Histologic confirmation by Pathology Department, NIH, required.

Recurrent disease after paclitaxel and either cisplatin or carboplatin. Combination
platinum/paclitaxel acceptable.

Bidimensionally measurable disease on physical exam, radiographs, or peritoneoscopy.
Repeat peritoneoscopy after 8 courses of therapy required if documentation of disease was
solely by peritoneoscopy.

Laparotomy not required.

No CNS metastasis.

No borderline or mixed histology.

PRIOR/CONCURRENT THERAPY:

See Disease Characteristics.

More than 4 weeks since any prior therapy and recovered.

No prior camptothecin analogue-based chemotherapy.

No prior radiotherapy except intraperitoneal 32-P.

PATIENT CHARACTERISTICS:

Age: 18 and over.

Performance status: ECOG 0-2.

Hematopoietic:

WBC greater than 3,000.

AGC greater than 1,500.

Platelets at least 100,000.

Hemoglobin greater than 9 g/dL OR;

Hematocrit greater than 27 g/dL.

Hepatic:

Bilirubin no greater than 1.5 mg/dL.

Serum transaminases no greater than 2 times normal.

Renal:

24-hour creatinine clearance greater than 45 mL/min (documented by NCI investigator or
primary care physician).

Cardiovascular:

No myocardial infarction within 12 months.

No active congestive heart failure.

No heart block.

No arrhythmia requiring medication.

OTHER:

No active uncontrolled infection.

No known HIV positivity.

No second malignancy currently under treatment except: Local basal cell carcinoma of the
skin, Cervical carcinoma in situ, Other malignancies (e.g., stage I breast cancer)
eligible at the discretion of the principal or associate investigators.

No pregnant women.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment

Authority:

United States: Federal Government

Study ID:

950056

NCT ID:

NCT00001427

Start Date:

January 1995

Completion Date:

April 2000

Related Keywords:

  • Ovarian Neoplasms
  • Pharmacodynamic Studies
  • Pharmacokinetics
  • Neoplasms
  • Ovarian Neoplasms

Name

Location

National Cancer Institute (NCI)Bethesda, Maryland  20892