Bevacizumab in Treating Patients With Recurrent or Persistent Endometrial Cancer

NCT00301964 | Completed Phase 2 Results

• 4 other identifiers: NCI-2012-02692CDR0000465502GOG-0229EU10CA027469
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial is studying how well bevacizumab works in treating patients with recurrent or persistent endometrial cancer. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor.

Conditions

Recurrent Endometrial Carcinoma

Outcome Measures

Primary Outcomes (3)

• Progression-free Survival Greater Than 6 Months

  Disease Progression is at least a 20% increase in the sum of longest dimension (LD) of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.

  6 months

• Best Tumor Response

  Response is measured according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.0): Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial Response (PR) is 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. Disease Progression is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry. Stable Disease is any condition not meeting the above criteria. Indeterminate is defined as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease.

  study entry through completion

• Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.

  Up to 5 years

Secondary Outcomes (4)

• Progression-free Survival

  Every other cycle for the first 6 months; then every 4 cycles until progression or death, up to 5 years.

• Overall Survival

  Every 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.

• Initial Performance Status

  Baseline

• Histologic Grade

  Baseline

Study Arms (1)

Treatment (bevacizumab)

EXPERIMENTAL

Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats 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:

• Recurrent or persistent endometrial carcinoma with histologic confirmation of the original primary tumor
• Refractory to curative therapy or established treatments
• Measurable disease
• At least one non previously irradiated lesion that can be accurately measured in ≥ 1 dimension as ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
• Previously irradiated lesion allowed provided disease progression is documented or a biopsy obtained to confirm persistent disease ≥ 90 days after completion of prior radiotherapy
• Must have received 1 prior chemotherapy regimen for endometrial carcinoma
• May include high-dose therapy, consolidation, or extended therapy after surgical or nonsurgical assessment
• Not eligible for a higher priority GOG protocol, if one exists
• No tumor involving major vessels
• No prior history or evidence of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, or any brain metastases
• GOG performance status (PS) 0-2 (if received 1 prior treatment regimen)
• GOG PS 0-1 (if received 2 prior treatment regimens)
• Absolute neutrophil count ≥ 1,000/mm³
• Platelet count ≥ 100,000/mm³
• Creatinine ≤ 1.5 times upper limit of normal (ULN)

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

Endometrial Neoplasms

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; 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: Jessalyn Reboy
• Organization: NRG Oncology, Statistics and Data Management Center, Buffalo Office

ReboyJ@nrgoncology.org

716-845-7738

Study Officials

• Carol Aghajanian

  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: March 9, 2006
• First Posted: March 13, 2006
• Study Start: March 1, 2006
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: July 24, 2019
• Results First Posted: November 26, 2014

Record last verified: 2019-07

Locations

US (1)