Paclitaxel in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer

• Status: Terminated
• 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 paclitaxel in treating patients who have recurrent or persistent ovarian epithelial cancer or primary peritoneal 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 recurrent or persistent ovarian epithelial or primary peritoneal cancer

• Measurable disease

• At least 1 lesion measured in at least 1 dimension

• At least 20 mm by conventional techniques OR

• At least 10 mm by spiral CT scan

• At least 1 target lesion

• Tumors within a previously irradiated field considered non-target lesions

• Paclitaxel resistant

• Treatment-free interval of less than 6 months duration after treatment with prior paclitaxel OR

• Progression during prior paclitaxel-based therapy

• Platinum resistant or refractory

• Treatment-free interval of less than 6 months duration after treatment with prior platinum OR

• Progression during prior platinum-based therapy

• Ineligible for higher priority GOG protocol (any active GOG phase III protocol for the same patient population)

PATIENT CHARACTERISTICS:

Age:

• Any age

Performance status:

• GOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)

• SGOT no greater than 2.5 times ULN

• Alkaline phosphatase no greater than 2.5 times ULN

Renal:

• Creatinine no greater than 1.5 times ULN

Other:

• Not pregnant

• Negative pregnancy test

• Fertile patients must use effective contraception

• No active infection requiring antibiotics

• No other prior invasive malignancy within the past 5 years except nonmelanoma skin cancer

• No grade 2 or greater neuropathy (sensory and motor)

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 3 weeks since prior biologic or immunologic agents for cancer

Chemotherapy:

• See Disease Characteristics

• At least 3 weeks since prior chemotherapy for cancer and recovered

• Received at least 1 but no more than 2 prior platinum-based chemotherapy regimens containing carboplatin, cisplatin, or other organoplatinum compound for primary or recurrent disease

• Initial treatment may include high-dose therapy, consolidation, or extended therapy

• Received at least 1 prior paclitaxel-based chemotherapy regimen

• No prior paclitaxel or docetaxel with a schedule of less than a 3-week interval between doses

• No additional prior cytotoxic chemotherapy for recurrent or persistent disease, including retreatment with initial chemotherapy regimens

Endocrine therapy:

• At least 1 week since prior hormonal therapy for cancer

• Concurrent hormone replacement therapy allowed

Radiotherapy:

• See Disease Characteristics

• At least 3 weeks since prior radiotherapy for cancer and recovered

• No prior radiotherapy to site(s) of measurable disease

• No prior radiotherapy to more than 25% of marrow-bearing areas

Surgery:

• At least 3 weeks since prior surgery for cancer and recovered

Other:

• At least 3 weeks since other prior therapy for cancer

• No prior anticancer treatment that would preclude study

• No concurrent amifostine or other protective reagents