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

DISEASE CHARACTERISTICS:

• 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

PATIENT CHARACTERISTICS:

• 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

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• 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
• No concurrent amifostine or other protective agents