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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


Phase 2
N/A
N/A
Open (Enrolling)
Female
Cervical Cancer

Thank you

Trial Information

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


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.

- 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.

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

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Antitumor activity

Safety Issue:

No

Principal Investigator

David S. Alberts, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Arizona

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000463520

NCT ID:

NCT00309959

Start Date:

May 2006

Completion Date:

Related Keywords:

  • Cervical Cancer
  • recurrent cervical cancer
  • cervical adenocarcinoma
  • cervical adenosquamous cell carcinoma
  • cervical small cell carcinoma
  • cervical squamous cell carcinoma
  • Uterine Cervical Neoplasms

Name

Location

CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
MetroHealth Cancer Care Center at MetroHealth Medical CenterCleveland, Ohio  44109
University of Wisconsin Paul P. Carbone Comprehensive Cancer CenterMadison, Wisconsin  53792-6164
Marshfield Clinic - Marshfield CenterMarshfield, Wisconsin  54449
Rush University Medical CenterChicago, Illinois  60612-3824
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
SUNY Downstate Medical CenterBrooklyn, New York  11203
Lake/University Ireland Cancer CenterMentor, Ohio  44060
Carilion Gynecologic Oncology AssociatesRoanoke, Virginia  24014
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
M. D. Anderson Cancer Center at University of TexasHouston, Texas  77030-4009
Virginia Commonwealth University Massey Cancer CenterRichmond, Virginia  23298-0037
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital MarltonMarlton, New Jersey  08053
Cancer Care Associates - Saint Francis CampusTulsa, Oklahoma  74136-1929
Rosenfeld Cancer Center at Abington Memorial HospitalAbington, Pennsylvania  19001
John Stoddard Cancer Center at Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Medical Oncology and Hematology Associates at John Stoddard Cancer CenterDes Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer CenterDes Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
Gynecologic OncologyHinsdale, Illinois  60521
University of Colorado Cancer Center at UC Health Sciences CenterAurora, Colorado  80045
Lyndon B. Johnson General HospitalHouston, Texas  77026-1967
Arizona Cancer Center at University Medical Center NorthTucson, Arizona  85719