ABI-007 in Treating Patients With Persistent or Recurrent Cervical Cancer
Condition: Cervical Adenocarcinoma; Cervical Adenosquamous Carcinoma; Cervical Small Cell Carcinoma; Cervical Squamous Cell Carcinoma; Recurrent Cervical Carcinoma
MeSH terms: Carcinoma; Carcinoma, Small Cell; Small Cell Lung Carcinoma; Carcinoma, Adenosquamous; Recurrence
Intervention: Paclitaxel Albumin-Stabilized Nanoparticle Formulation; Laboratory Biomarker Analysis
Intervention description: Given IV; Correlative studies
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: Female
Healthy volunteers: No

Summary:

      This phase II trial is studying how well ABI-007 works in treating patients with persistent
      or recurrent cervical cancer. Drugs used in chemotherapy, such as ABI-007, work in different
      ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing.
    

Eligibility criteria:

        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