A Phase II Evaluation of Abraxane® in the Treatment of Recurrent or Persistent Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed diagnosis of 1 of the following:

- Ovarian epithelial cancer

- Fallopian tube cancer

- Primary peritoneal carcinoma

- Recurrent or persistent disease

- Must have received 1 prior platinum-based chemotherapy regimen containing
carboplatin, cisplatin, or another organoplatinum compound for management of primary
disease

- Initial treatment may have included intraperitoneal therapy, high-dose therapy,
consolidation therapy, or extended therapy administered after a surgical or
nonsurgical assessment

- Patients who have not received prior paclitaxel-based chemotherapy must receive
a second regimen that includes paclitaxel or docetaxel

- Platinum-resistant or refractory disease, defined by 1 of the following:

- Treatment-free interval of < 6 months after completion of platinum-based therapy

- Persistent disease at completion of primary platinum-based therapy

- Progressive disease during platinum-based therapy

- Paclitaxel-resistant disease, defined as having had a treatment-free interval < 6
months or shown disease progression during paclitaxel-based therapy

- Patients who have not received prior paclitaxel-based chemotherapy must receive
a second regimen that includes paclitaxel or docetaxel

- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by
conventional techniques or ≥ 10 mm by spiral CT scan

- Must have ≥ 1 target lesion that can be used to assess response

- Tumors within a previously irradiated field are designated as non-target lesions
unless progression is documented or biopsy confirms persistence ≥ 90 days after
completion of radiotherapy

- Not a candidate for a higher priority GOG protocol

PATIENT CHARACTERISTICS:

- GOG performance status 0-2

- ANC ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Hemoglobin ≥ 9.0 g/dL

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

- Bilirubin normal

- SGOT ≤ 2.5 times ULN

- Alkaline phosphatase ≤ 2.5 times ULN

- No active infection requiring antibiotics

- No sensory or motor neuropathy > grade 1

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- PT INR ≤ 1.5 or in-range INR 2-3 (if patient is on a stable dose of therapeutic
warfarin)

- PTT < 1.2 times control

- No concurrent serious medical or psychiatric illness, including serious active
infection

- No uncontrolled hypertension (i.e., blood pressure ≥ 150/100 mm Hg)

- No uncompensated congestive heart failure or symptomatic coronary artery disease

- No myocardial infarction within the past 6 months

- No active bleeding

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

- No history of allergic reactions attributed to chemical or biological composition to
paclitaxel or other study agents

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- Recovered from prior surgery, radiotherapy, or chemotherapy

- No prior paclitaxel albumin-stabilized nanoparticle formulation (Abraxane®)

- No prior cancer treatment that would preclude study therapy

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

- One additional prior noncytotoxic regimen (i.e., monoclonal antibodies, cytokines, or
small molecule inhibitors of signal transduction) for management of recurrent or
persistent disease allowed

- At least 1 week since prior hormonal therapy directed at the malignant tumor

- Concurrent hormone replacement therapy allowed

- At least 3 weeks since other prior therapy directed at the malignant tumor, including
biologic therapy, immunologic agents, or radiotherapy

- More than 5 years since prior chemotherapy for any other portion of the abdominal
cavity or pelvis, unless for treatment of ovarian, primary peritoneal, or fallopian
tube cancer

- Prior adjuvant chemotherapy for localized breast cancer allowed provided it was
completed > 3 years ago and patient remains free of recurrent or metastatic
disease

- More than 5 years since prior radiotherapy to any other portion of the abdominal
cavity or pelvis, unless for treatment of ovarian, primary peritoneal, or fallopian
tube cancer

- Prior radiotherapy for localized breast cancer, cancer of the head and neck, or
skin cancer allowed provided it was completed > 3 years ago and patient remains
free of recurrent or metastatic disease

- No prior radiotherapy to > 25% of marrow-bearing areas

- No concurrent amifostine or other protective reagents