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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gynecologic Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

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