ABI-007 in Treating Patients With Persistent or Recurrent Cervical Cancer
NCT ID: NCT00309959
Last Updated: 2019-01-08
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
37 participants
INTERVENTIONAL
2006-11-30
Brief Summary
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Detailed Description
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I. Estimate the antitumor activity of ABI-007 in patients with persistent or recurrent squamous or nonsquamous cell carcinoma of the cervix who have failed on higher-priority treatment protocols.
II. Determine the nature and degree of toxicity of ABI-007 in this cohort of patients.
III. To determine the expression of the SPARC (secreted protein, acidic and rich in cysteine) protein in the tumor tissue and plasma (exploratory study) of patients treated with this regimen.
OUTLINE: This is an open-label, multicenter study.
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.
Blood samples are collected at baseline and periodically during study for SPARC protein expression analysis by ELISA. Archived tumor tissue samples are also analyzed.
After completion of study treatment, patients are followed periodically for up to 5 years.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Paclitaxel Albumin-Stabilized Nanoparticle Formulation
Given IV
Laboratory Biomarker Analysis
Correlative studies
Interventions
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Paclitaxel Albumin-Stabilized Nanoparticle Formulation
Given IV
Laboratory Biomarker Analysis
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Gynecologic Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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David Alberts
Role: PRINCIPAL_INVESTIGATOR
Gynecologic Oncology Group
Locations
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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
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
Countries
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Other Identifiers
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NCI-2009-00576
Identifier Type: REGISTRY
Identifier Source: secondary_id
GOG-0127V
Identifier Type: -
Identifier Source: secondary_id
CDR0000463520
Identifier Type: -
Identifier Source: secondary_id
GOG-0127V
Identifier Type: OTHER
Identifier Source: secondary_id
GOG-0127V
Identifier Type: OTHER
Identifier Source: secondary_id
GOG-0127V
Identifier Type: -
Identifier Source: org_study_id
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