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Status:

COMPLETED

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

Lead Sponsor:

Gynecologic Oncology Group

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Cervical Adenocarcinoma

Cervical Adenosquamous Carcinoma

Eligibility:

FEMALE

Phase:

PHASE2

Brief 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 th...

Detailed Description

OBJECTIVES: 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 pr...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    November 1 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    37 Patients enrolled

    Trial Details

    Trial ID

    NCT00309959

    Start Date

    November 1 2006

    Last Update

    January 8 2019

    Active Locations (26)

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    Page 1 of 7 (26 locations)

    1

    University of Colorado Cancer Center - Anschutz Cancer Pavilion

    Aurora, Colorado, United States, 80045

    2

    Rush University Medical Center

    Chicago, Illinois, United States, 60612

    3

    Carle Clinic-Urbana Main

    Urbana, Illinois, United States, 61801

    4

    Iowa Methodist Medical Center

    Des Moines, Iowa, United States, 50309