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

Completed · Phase 2

Conditions studied: Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Cervical Small Cell Carcinoma, Cervical Squamous Cell Carcinoma, Recurrent Cervical Carcinoma

In brief

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.

Key facts

Study ID

NCT00309959

Run by

Gynecologic Oncology Group

People needed

37

Starts

2006-11-01

Last updated by the study team

2019-01-08

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• University of Colorado Cancer Center - Anschutz Cancer Pavilion — Aurora, Colorado, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Carle Clinic-Urbana Main — Urbana, Illinois, United States
• Iowa Methodist Medical Center — Des Moines, Iowa, United States
• Iowa Oncology Research Association CCOP — Des Moines, Iowa, United States
• Medical Oncology and Hematology Associates-Des Moines — Des Moines, Iowa, United States
• Medical Oncology and Hematology Associates-Laurel — Des Moines, Iowa, United States
• Mercy Medical Center - Des Moines — Des Moines, Iowa, United States
• Iowa Lutheran Hospital — Des Moines, Iowa, United States
• Mercy Hospital Springfield — Springfield, Missouri, United States
• Women's Cancer Center of Nevada — Las Vegas, Nevada, United States
• Cooper Hospital University Medical Center — Camden, New Jersey, United States
• Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County — Mount Holly, New Jersey, United States
• Virtua West Jersey Hospital Voorhees — Voorhees Township, New Jersey, United States
• Women's Cancer Care Associates LLC — Albany, New York, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Lake University Ireland Cancer Center — Mentor, Ohio, United States
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
• Tulsa Cancer Institute — Tulsa, Oklahoma, United States
• Abington Memorial Hospital — Abington, Pennsylvania, United States
• Lyndon Baines Johnson General Hospital — Houston, Texas, United States
• M D Anderson Cancer Center — Houston, Texas, United States
• Carilion Clinic Gynecological Oncology — Roanoke, Virginia, United States
• Saint Vincent Hospital — Green Bay, Wisconsin, United States

Full record on ClinicalTrials.gov

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