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

Phase 2

Completed

• Conditions: Cervical Adenocarcinoma; Cervical Adenosquamous Carcinoma; Recurrent Cervical Carcinoma; Cervical Small Cell Carcinoma; Cervical Squamous Cell Carcinoma
• Interventions: Drug: Paclitaxel Albumin-Stabilized Nanoparticle Formulation; Other: Laboratory Biomarker Analysis

• Registration Number: NCT00309959
• Lead Sponsor: Gynecologic Oncology Group

Brief 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.

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.

Study Timeline

• Study First Submitted: 2006-03-29
• Study First Submitted QC: 2006-03-29
• Study First Posted: 2006-04-03
• Study Start: 2006-11
• Primary Completion: 2011-02
• Status Verified: 2014-12
• Results First Submitted: 2018-08-30
• Results First Submitted QC: 2018-12-17
• Last Update Submitted: 2018-12-17
• Results First Posted: 2019-01-08
• Last Update Posted: 2019-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 37

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (paclitaxel albumin-stabilized nanoparticle)	Laboratory Biomarker Analysis	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.
Treatment (paclitaxel albumin-stabilized nanoparticle)	Paclitaxel Albumin-Stabilized Nanoparticle Formulation	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.

Primary Outcome Measures

Name	Time	Method
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
Proportion of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0	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.	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.

Trial Locations

Locations (26)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

University of Colorado Cancer Center - Anschutz Cancer Pavilion; 🇺🇸 Aurora, Colorado, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

Iowa Methodist Medical Center; 🇺🇸 Des Moines, Iowa, United States

Iowa Oncology Research Association CCOP; 🇺🇸 Des Moines, Iowa, United States

Mercy Medical Center - Des Moines; 🇺🇸 Des Moines, Iowa, United States

Mercy Hospital Springfield; 🇺🇸 Springfield, Missouri, United States

Women's Cancer Center of Nevada; 🇺🇸 Las Vegas, Nevada, United States

Cooper Hospital University Medical Center; 🇺🇸 Camden, New Jersey, United States

Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County; 🇺🇸 Mount Holly, New Jersey, United States

Virtua West Jersey Hospital Voorhees; 🇺🇸 Voorhees, New Jersey, United States

Tulsa Cancer Institute; 🇺🇸 Tulsa, Oklahoma, United States

Lake University Ireland Cancer Center; 🇺🇸 Mentor, Ohio, United States

University of Oklahoma Health Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States

Abington Memorial Hospital; 🇺🇸 Abington, Pennsylvania, United States

Saint Vincent Hospital; 🇺🇸 Green Bay, Wisconsin, United States

Carilion Clinic Gynecological Oncology; 🇺🇸 Roanoke, Virginia, United States

University of Wisconsin Hospital and Clinics; 🇺🇸 Madison, Wisconsin, United States

Women's Cancer Care Associates LLC; 🇺🇸 Albany, New York, United States

Carle Clinic-Urbana Main; 🇺🇸 Urbana, Illinois, United States

Medical Oncology and Hematology Associates-Laurel; 🇺🇸 Des Moines, Iowa, United States

Medical Oncology and Hematology Associates-Des Moines; 🇺🇸 Des Moines, Iowa, United States

Iowa Lutheran Hospital; 🇺🇸 Des Moines, Iowa, United States

Lyndon Baines Johnson General Hospital; 🇺🇸 Houston, Texas, United States

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States