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ABI-007 in Treating Patients With Persistent or Recurrent Cervical Cancer
This study has been suspended.
Study NCT00309959   Information provided by National Cancer Institute (NCI)
First Received: March 29, 2006   Last Updated: July 23, 2008   History of Changes
This Tabular View shows the required WHO registration data elements as marked by

March 29, 2006
July 23, 2008
May 2006
  • Antitumor activity [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00309959 on ClinicalTrials.gov Archive Site
 
 
 
ABI-007 in Treating Patients With Persistent or Recurrent Cervical Cancer
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

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.

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.

Phase II
Interventional
Treatment, Open Label
Cervical Cancer
Drug: paclitaxel albumin-stabilized nanoparticle formulation
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Suspended
60
 
October 2008   (final data collection date for primary outcome measure)

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
Female
 
No
 
United States
 
 
NCT00309959
 
GOG-0127V
Gynecologic Oncology Group
National Cancer Institute (NCI)
Study Chair: David S. Alberts, MD University of Arizona
National Cancer Institute (NCI)
March 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.