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
  Purpose

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.


Condition Intervention Phase
Cervical Adenocarcinoma
Cervical Adenosquamous Cell Carcinoma
Cervical Small Cell Carcinoma
Cervical Squamous Cell Carcinoma
Recurrent Cervical Cancer
Drug: paclitaxel albumin-stabilized nanoparticle formulation
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: November 2006
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

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 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.

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00309959

  Show 27 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Principal Investigator: David Alberts Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00309959     History of Changes
Other Study ID Numbers: GOG-0127V, NCI-2009-00576, GOG-0127V, CDR0000463520, GOG-0127V, GOG-0127V, U10CA027469
Study First Received: March 29, 2006
Last Updated: November 22, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Carcinoma, Adenosquamous
Carcinoma, Small Cell
Carcinoma, Squamous Cell
Small Cell Lung Carcinoma
Uterine Cervical Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Genital Diseases, Female
Genital Neoplasms, Female
Lung Diseases
Lung Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Complex and Mixed
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on October 30, 2014