Overview

Paclitaxel in Treating Patients With Advanced, Refractory, or Recurrent Cervical or Vaginal Cancer

Status:
Completed
Trial end date:
2004-08-01
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 paclitaxel in treating patients with advanced, refractory, or recurrent cervical or vaginal cancer.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Gynecologic Oncology Group
Collaborator:
National Cancer Institute (NCI)
Treatments:
Albumin-Bound Paclitaxel
Paclitaxel
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed advanced, persistent, or recurrent clear
cell adenocarcinoma of the vagina or cervix Documented disease progression after local
therapy required Disease must be considered incurable Bidimensionally measurable disease
required by physical examination or medical imaging

PATIENT CHARACTERISTICS: Age: Any age Performance status: GOG 0-2 Hematopoietic: WBC at
least 3,000 AGC at least 1,500 Platelets at least 100,000 Hepatic: Bilirubin no more than
1.5 times normal AST no more than 3 times normal Alkaline phosphatase no more than 3 times
normal Renal: Creatinine no more than 2.0 mg/dL Other: Not eligible for a higher priority
GOG protocol No significant infection No prior or concomitant second malignancy except
nonmelanomatous skin cancer

PRIOR CONCURRENT THERAPY: At least 3 weeks since therapy directed at malignancy Biologic
therapy: Not specified Chemotherapy: No more than 1 prior chemotherapy regimen (either
single or combination cytotoxic drug therapy) No prior paclitaxel Recovery from prior
chemotherapy required Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy
for recurrent disease except a low dose, single fraction used to abrogate menorrhagia
Recovery from prior radiotherapy required Surgery: Recovery from prior surgery required