ABI-007 in Treating Patients With Persistent or Recurrent Cervical Cancer

Inclusion Criteria

• Persistent or recurrent squamous or nonsquamous cell carcinoma of the cervix with documented disease progression
• Histologic confirmation of the original primary tumor
• Measurable disease, defined as at least one target lesion that can be accurately measured in at least one dimension ≥ 20 mm when measured by conventional techniques, including palpation, plain x-ray, CT scan, or MRI, or ≥ 10 mm when measured by spiral CT scan
• Tumors within a previously irradiated field will be designated as nontarget lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days after completion of radiotherapy
• Must have received 1 prior systemic chemotherapeutic regimen for management of advanced, metastatic, or recurrent squamous or nonsquamous cell carcinoma of the cervix
• Chemotherapy administered as a radiosensitizer is not a systemic chemotherapy regimen
• Not eligible for a higher priority GOG protocol
• GOG performance status 0, 1, or 2
• No active infection requiring antibiotics
• Platelet count ≥ 100,000/mm^3
• Absolute neutrophil count ≥ 1,500/mm^3
• Creatinine ≤ 1.5 times upper limit of normal (ULN)
• Bilirubin ≤ 1.5 times ULN
• SGOT and alkaline phosphatase ≤ 2.5 times ULN
• No neuropathy (sensory and motor) > grade 1
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No evidence of any other invasive malignancies within the past 3-5 years, except localized breast cancer, head and neck cancer, cervical cancer, or nonmelanoma skin cancer
• No pre-existing hearing loss/tinnitus > grade 1
• No concurrent amifostine or other protective agents
• Recovered from effects of prior surgery, radiotherapy, or chemotherapy
• Hormonal therapy directed at malignant tumor must be discontinued at least 1 week prior to study entry
• Continuation of hormone replacement therapy permitted
• At least 3 weeks since prior biological therapy and immunotherapy
• No more than 1 prior cytotoxic chemotherapy regimen (either with single or combination cytotoxic drug therapy)
• May have received 1 additional noncytotoxic (biologic or cytostatic) regimen, including monoclonal antibodies, cytokines, or small-molecule inhibitors of signal transduction
• No prior radiotherapy to any portion of the abdominal cavity or pelvis
• Radiotherapy for the treatment of cervical cancer within the past 5 years allowed
• Radiotherapy for localized breast cancer, head and neck or skin allowed provided completion > 3 years prior to study entry and remains free of recurrent or metastatic disease
• No prior chemotherapy for any abdominal or pelvic tumor
• Chemotherapy for the treatment of cervical cancer within the past 5 years allowed
• Prior adjuvant chemotherapy for localized breast cancer provided completion > 3 years prior to study entry and remains free of recurrent or metastatic disease
• No prior therapy with ABI-007 or any other taxane
• No prior anticancer treatment that would preclude study therapy
• No concurrent ritonavir, saquinavir, indinavir, nelfinavir, or anticonvulsants