Overview

Paclitaxel in Treating Patients With Recurrent or Persistent Ovarian or Primary Peritoneal Cancer

Status:
Completed
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 I trial to study the effectiveness of paclitaxel in treating patients who have recurrent or persistent ovarian or primary peritoneal cancer.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Gynecologic Oncology Group
Collaborator:
National Cancer Institute (NCI)
Treatments:
Albumin-Bound Paclitaxel
Paclitaxel
Criteria
DISEASE CHARACTERISTICS: Recurrent or persistent ovarian and/or primary peritoneal
carcinoma Adequate potential intraperitoneal fluid distribution with no gross fluid
loculations and adhesions that would significantly affect intraperitoneal drug distribution

PATIENT CHARACTERISTICS: Age: 21 and over Performance status: GOG 0-2 Life expectancy: At
least 6 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 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 Renal: Creatinine less than 2.0
mg/dL Other: No other sufficiently severe medical problems unrelated to malignancy that
would preclude study compliance or cause exposure to undue risks No prior unmanageable
reaction to paclitaxel

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks
since prior myelosuppressive chemotherapy (6 weeks for nitrosourea and mitomycin) and
recovered Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior
radiotherapy to major bone marrow containing areas Surgery: Not specified Other: At least 1
month since other prior investigational agents