Bevacizumab in Treating Patients With Persistent or Recurrent Cancer of the Cervix

NCT00025233 | Completed Phase 2 Results

• 4 other identifiers: NCI-2012-02416CDR0000068940GOG-0227CU10CA027469
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial is to see if bevacizumab works in treating patients who have persistent or recurrent cancer of the cervix. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them.

Conditions

Cervical Squamous Cell Carcinoma; Recurrent Cervical Cancer

Outcome Measures

Primary Outcomes (2)

• Progression-free Survival Greater Than 6 Months

  Whether or not the patient survived progression-free for at least 6 months.

  Every other 3-week treatment cycle for 6 months

• Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0

  The maximum severity of each adverse event per patient, graded according to Common Toxicity Criteria version 2.0, is reported. Events were restricted to those reported as at least possibly related to study drug.

  Every cycle and 30 days after the end of treatment. (average 5 months)

Secondary Outcomes (5)

• Tumor Response

  Every other cycle during treatment and at the time of treatment discontinuation. (average 5 months)

• Overall Survival

  From study entry to death or last contact, up to 5 years.

• Duration of Progression-free Survival

  Every other cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years

• Performance Status

  Baseline

• Age at Enrollment

  Baseline

Study Arms (1)

Treatment (bevacizumab)

EXPERIMENTAL

Patients receive bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Biological: bevacizumab; Other: laboratory biomarker analysis

Interventions

bevacizumab BIOLOGICAL

Given IV

Also known as: anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, Avastin, rhuMAb VEGF

Treatment (bevacizumab)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (bevacizumab)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed persistent or recurrent squamous cell carcinoma (SCC) of the cervix
• Patients must have received at least 1, but no more than 2, prior cytotoxic chemotherapy regimens for advanced, metastatic, or recurrent SCC of the cervix
• Chemotherapy administered as a radio-sensitizer does not count as 1 regimen
• Documented disease progression
• At least 1 unidimensionally measurable lesion\*
• At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
• No tumor involving major blood vessels
• No history or physical evidence of CNS disease, including primary or metastatic brain tumor
• Ineligible for a higher priority Gynecological Oncology Group (GOG) protocol (if one exists), including any active GOG phase III protocol for the same patient population
• Performance status - GOG 0-2 (if received 1 prior regimen)
• Performance status - GOG 0-1 (if received 2 prior regimens)
• Absolute neutrophil count ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• No known bleeding disorder or coagulopathy
• No other active bleeding or pathologic condition that would confer a high risk of bleeding

Sponsors & Collaborators

• National Cancer Institute (NCI): lead
• Gynecologic Oncology Group: collaborator

Study Sites (1)

Gynecologic Oncology Group

Philadelphia, Pennsylvania, 19103, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Angela M. Kuras, Associate Director of Data Management
• Organization: NRG Oncology Statistics and Data Management Center - Buffalo

kurasa@nrgoncology.org

716-845-7733

Study Officials

• Bradley Monk

  Gynecologic Oncology Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2001
• First Posted: January 27, 2003
• Study Start: April 1, 2002
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: July 24, 2019
• Results First Posted: June 29, 2015

Record last verified: 2019-07

Locations

US (1)