A Randomized Phase III Trial of Maintenance Chemotherapy Comparing 12 Monthly Cycles of Single Agent Paclitaxel or Xyotax (CT-2103) (IND# 70177), Versus No Treatment Until Documented Relapse in Women With Advanced Ovarian or Primary Peritoneal or Fallopian Tube Cancer Who Achieve a Complete Clinical Response to Primary Platinum/Taxane Chemotherapy

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed stage III or IV ovarian epithelial or primary peritoneal
cancer or fallopian tube cancer

- The following histologic epithelial cell types are allowed:

- Serous adenocarcinoma

- Endometrioid adenocarcinoma

- Mucinous adenocarcinoma

- Undifferentiated carcinoma

- Clear cell adenocarcinoma

- Mixed epithelial carcinoma

- Transitional cell carcinoma

- Malignant Brenner tumor

- Adenocarcinoma not otherwise specified

- The following histologic cell types are not allowed:

- Germ cell tumor

- Sex cord-stromal tumor

- Carcinosarcoma

- Mixed müllerian tumor or carcinosarcoma

- Metastatic carcinoma from other sites to the ovary

- Low malignant potential (LMP) tumor (borderline carcinoma), including
micropapillary serous carcinoma

- Patients with a prior diagnosis of LMP tumor that was surgically resected
and who subsequently developed invasive adenocarcinoma are eligible
provided patient did not receive prior chemotherapy for the ovarian LMP
tumor

- Must have undergone surgery for ovarian epithelial or primary peritoneal cancer AND
have tissue available for histologic evaluation

- Optimal (≤ 1 cm) residual disease OR suboptimal residual disease after initial
surgery

- Must have completed at least 5, but no more that 8 courses of primary therapy
comprising carboplatin (IV or intraperitoneal) AND paclitaxel or docetaxel-based
combination chemotherapy within the past 12 weeks AND have no symptoms of persistent
cancer after completion of therapy

- CT scan of the abdomen and/or pelvis normal

- CA 125 normal

- Patients treated with neo-adjuvant platinum-taxane chemotherapy for a presumptive
diagnosis of stage III or IV primary peritoneal carcinoma or epithelial ovarian
carcinoma (by paracentesis, percutaneous biopsy or open biopsy) are eligible provided
the following criteria is met:

- Must have undergone interval abdominal surgery after at least one but no more
than 6 courses of standard chemotherapy

- Surgery must meet the same criteria as the up front surgery, including
tissue diagnosis for confirmation of primary tumor site and stage III or IV
disease

- Patients must have received at least 2 courses after interval abdominal
surgery

- No synchronous primary endometrial cancer or history of primary endometrial cancer,
unless all of the following criteria are met:

- Stage ≤ IB

- Less than 3 mm invasion without vascular or lymphatic invasion

- No poorly differentiated subtypes, including papillary serous, clear cell, or
other FIGO grade 3 lesion

PATIENT CHARACTERISTICS:

Age

- Not specified

Performance status

- GOG 0-2

Life expectancy

- Not specified

Hematopoietic

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- No active bleeding

Hepatic

- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- SGOT ≤ 2.5 times ULN

- Alkaline phosphatase ≤ 2.5 times ULN

- PT or PTT normal

- No acute or chronic hepatitis

Renal

- Creatinine ≤ 1.5 times ULN

Cardiovascular

- Abnormal cardiac conduction (e.g., bundle branch block or heart block) allowed
provided the disease has remained stable within the past 6 months

- No unstable angina

- No myocardial infarction within the past 6 months

Other

- No neuropathy (sensory and motor) ≥ grade 2

- No active infection requiring antibiotics

- No ongoing gastrointestinal bleeding requiring blood product support

- No circumstance that would preclude study participation

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

- Not pregnant or nursing

- Fertile patients must agree to use an effective contraception method

- Negative pregnancy test

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No prior biologic therapy (e.g., bevacizumab or erlotinib) for any other abdominal or
pelvic tumor

Chemotherapy

- See Disease Characteristics

- No prior polyglutamate paclitaxel

- No prior chemotherapy for any other abdominal or pelvic tumor

- More than 3 years since prior adjuvant chemotherapy for localized breast cancer AND
no recurrent or metastatic disease

Endocrine therapy

- Not specified

Radiotherapy

- No prior radiotherapy to any portion of the abdominal cavity or pelvis

- More than 3 years since prior radiotherapy for localized cancer of the breast, head
and neck, or skin AND no recurrent or metastatic disease

Surgery

- See Disease Characteristics

Other

- No prior investigational therapy for any other abdominal or pelvic tumor

- No prior anticancer therapy that would preclude study therapy

- No concurrent amifostine or other protective agents