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ABI-007 in Treating Patients With Persistent or Recurrent Cervical Cancer
This study has been suspended.
Sponsors and Collaborators: Gynecologic Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00309959
  Purpose

RATIONALE: 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.

PURPOSE: This phase II trial is studying how well ABI-007 works in treating patients with persistent or recurrent cervical cancer.


Condition Intervention Phase
Cervical Cancer
Drug: paclitaxel albumin-stabilized nanoparticle formulation
Phase II

MedlinePlus related topics: Cancer
Drug Information available for: Paclitaxel
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Evaluation of ABI-007 (IND #55,974) in the Treatment of Persistent or Recurrent Squamous or Nonsquamous Cell Carcinoma of the Cervix

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Antitumor activity [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: May 2006
Estimated Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • 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.
  • Determine the nature and degree of toxicity of ABI-007 in this cohort of patients.

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.

After completion of study treatment, patients are followed periodically for up to 5 years.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • 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
  • No concurrent amifostine or other protective agents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00309959

  Show 27 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: David S. Alberts, MD University of Arizona
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000463520, GOG-0127V
Study First Received: March 29, 2006
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00309959  
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
recurrent cervical cancer
cervical adenocarcinoma
cervical adenosquamous cell carcinoma
cervical small cell carcinoma
cervical squamous cell carcinoma

Study placed in the following topic categories:
Epidermoid carcinoma
Carcinoma, Small Cell
Paclitaxel
Squamous cell carcinoma
Carcinoma, squamous cell
Adenocarcinoma
Carcinoma, Squamous Cell
Carcinoma, Adenosquamous
Recurrence
Carcinoma

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Mitosis Modulators
Tubulin Modulators
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009