ABI-007 in Treating Patients With Persistent or Recurrent Cervical Cancer
Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Cervical Small Cell Carcinoma
About this trial
This is an interventional treatment trial for Cervical Adenocarcinoma
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
Sites / Locations
- University of Colorado Cancer Center - Anschutz Cancer Pavilion
- Rush University Medical Center
- Carle Clinic-Urbana Main
- Iowa Methodist Medical Center
- Iowa Oncology Research Association CCOP
- Medical Oncology and Hematology Associates-Des Moines
- Medical Oncology and Hematology Associates-Laurel
- Mercy Medical Center - Des Moines
- Iowa Lutheran Hospital
- Mercy Hospital Springfield
- Women's Cancer Center of Nevada
- Cooper Hospital University Medical Center
- Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County
- Virtua West Jersey Hospital Voorhees
- Women's Cancer Care Associates LLC
- University of North Carolina
- Cleveland Clinic Foundation
- Lake University Ireland Cancer Center
- University of Oklahoma Health Sciences Center
- Tulsa Cancer Institute
- Abington Memorial Hospital
- Lyndon Baines Johnson General Hospital
- M D Anderson Cancer Center
- Carilion Clinic Gynecological Oncology
- Saint Vincent Hospital
- University of Wisconsin Hospital and Clinics
Arms of the Study
Arm 1
Experimental
Treatment (paclitaxel albumin-stabilized nanoparticle)
Patients receive ABI-007 IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.