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

Cervical Adenocarcinoma Clinical Trial

Official title:

A Phase II Evaluation of ABI-007 in the Treatment of Persistent or Recurrent Squamous or Nonsquamous Cell Carcinoma of the Cervix

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00309959
• Other study ID #: GOG-0127V
• Secondary ID: NCI-2009-00576GO
• Status: Completed
• Phase: Phase 2
• Start date: November 2006

Study information

• Verified date: December 2014
• Source: Gynecologic Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma
• Carcinoma, Adenosquamous
• Carcinoma, Small Cell
• Carcinoma, Squamous Cell
• Cervical Adenocarcinoma
• Cervical Adenosquamous Carcinoma
• Cervical Small Cell Carcinoma
• Cervical Squamous Cell Carcinoma
• Recurrent Cervical Carcinoma
• Small Cell Lung Carcinoma

Intervention

Drug:
• Paclitaxel Albumin-Stabilized Nanoparticle Formulation
Given IV

Other:
• Laboratory Biomarker Analysis
Correlative studies

Locations

Country	Name	City	State
United States	Abington Memorial Hospital	Abington	Pennsylvania
United States	Women's Cancer Care Associates LLC	Albany	New York
United States	University of Colorado Cancer Center - Anschutz Cancer Pavilion	Aurora	Colorado
United States	Cooper Hospital University Medical Center	Camden	New Jersey
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Rush University Medical Center	Chicago	Illinois
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Iowa Lutheran Hospital	Des Moines	Iowa
United States	Iowa Methodist Medical Center	Des Moines	Iowa
United States	Iowa Oncology Research Association CCOP	Des Moines	Iowa
United States	Medical Oncology and Hematology Associates-Des Moines	Des Moines	Iowa
United States	Medical Oncology and Hematology Associates-Laurel	Des Moines	Iowa
United States	Mercy Medical Center - Des Moines	Des Moines	Iowa
United States	Saint Vincent Hospital	Green Bay	Wisconsin
United States	Lyndon Baines Johnson General Hospital	Houston	Texas
United States	M D Anderson Cancer Center	Houston	Texas
United States	Women's Cancer Center of Nevada	Las Vegas	Nevada
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin
United States	Lake University Ireland Cancer Center	Mentor	Ohio
United States	Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County	Mount Holly	New Jersey
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	Carilion Clinic Gynecological Oncology	Roanoke	Virginia
United States	Mercy Hospital Springfield	Springfield	Missouri
United States	Tulsa Cancer Institute	Tulsa	Oklahoma
United States	Carle Clinic-Urbana Main	Urbana	Illinois
United States	Virtua West Jersey Hospital Voorhees	Voorhees	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0	RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.	CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; then every 3 months x 2; then every 6 months until disease progression for up to 5 years.
Primary	Frequency and Severity of Observed Adverse Effects Assessed by Common Terminology Criteria for Adverse Events (CTCAE)		Up to 5 yearsAssessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up