A Phase II Evaluation of Weekly Paclitaxel in the Treatment of Recurrent or Persistent Platinum and Paclitaxel-Resistant Ovarian or Primary Peritoneal Cancer

Inclusion 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