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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00309959
First received: March 29, 2006
Last updated: November 22, 2013
Last verified: November 2013

March 29, 2006
November 22, 2013
November 2006
February 2011   (final data collection date for primary outcome measure)
  • Frequency and duration of objective response assessed by Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Frequency and severity of observed adverse effects assessed by Common Terminology Criteria for Adverse Events (CTCAE) [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
  • Survival time [ Time Frame: From study entry to death or date of last contact, up to 5 years ] [ Designated as safety issue: No ]
  • Duration of progression-free interval [ Time Frame: From study entry until disease progression, death or date of last contact, up to 5 years ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00309959 on ClinicalTrials.gov Archive Site
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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

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.

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 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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cervical Adenocarcinoma
  • Cervical Adenosquamous Cell Carcinoma
  • Cervical Small Cell Carcinoma
  • Cervical Squamous Cell Carcinoma
  • Recurrent Cervical Cancer
  • Drug: paclitaxel albumin-stabilized nanoparticle formulation
    Given IV
    Other Names:
    • ABI-007
    • nab paclitaxel
    • nab-paclitaxel
    • nanoparticle albumin-bound paclitaxel
  • Other: laboratory biomarker analysis
    Correlative studies
Experimental: 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.
Interventions:
  • Drug: paclitaxel albumin-stabilized nanoparticle formulation
  • Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
Not Provided
February 2011   (final data collection date for primary outcome measure)

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
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00309959
GOG-0127V, NCI-2009-00576, GOG-0127V, CDR0000463520, GOG-0127V, GOG-0127V, U10CA027469
Not Provided
Gynecologic Oncology Group
Gynecologic Oncology Group
National Cancer Institute (NCI)
Principal Investigator: David Alberts Gynecologic Oncology Group
Gynecologic Oncology Group
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP