NCT00006089

Brief Summary

Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Phase II trial to study the effectiveness of trastuzumab in treating patients who have stage III, stage IV, or recurrent endometrial cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2000

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2000

Completed
2 months until next milestone

Study Start

First participant enrolled

September 18, 2000

Completed
2.4 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2007

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2010

Completed
Last Updated

July 31, 2019

Status Verified

July 1, 2019

Enrollment Period

7 years

First QC Date

August 3, 2000

Last Update Submit

July 30, 2019

Conditions

Endometrial AdenocarcinomaERBB2 Gene AmplificationRecurrent Uterine Corpus CarcinomaStage III Uterine Corpus Cancer AJCC v7Stage IV Uterine Corpus Cancer AJCC v7

Outcome Measures

Primary Outcomes (2)

  • Frequency and duration of objective response

    Up to 5 years

  • Frequency and severity of observed adverse effects assessed using Common Terminology Criteria (CTC) version 2.0

    Up to 5 years

Secondary Outcomes (3)

  • Duration of progression-free survival

    From study entry until disease progression, death or date or last contact, assessed up to 5 years

  • Duration of overall survival

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

  • Prognostic factors (i.e., initial performance status and histological grade)

    Not Provided

Study Arms (1)

Treatment (trastuzumab)

EXPERIMENTAL

Patients receive trastuzumab (Herceptin) IV over 30-90 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Other: Laboratory Biomarker AnalysisBiological: Trastuzumab

Interventions

Laboratory Biomarker AnalysisOTHER

Correlative studies

Treatment (trastuzumab)
TrastuzumabBIOLOGICAL

Given IV

Also known as: ABP 980, ALT02, Anti-c-ERB-2, Anti-c-erbB2 Monoclonal Antibody, Anti-ERB-2, Anti-erbB-2, Anti-erbB2 Monoclonal Antibody, Anti-HER2/c-erbB2 Monoclonal Antibody, Anti-p185-HER2, c-erb-2 Monoclonal Antibody, HER2 Monoclonal Antibody, Herceptin, Herceptin Biosimilar PF-05280014, Herceptin Trastuzumab Biosimilar PF-05280014, Herzuma, MoAb HER2, Monoclonal Antibody c-erb-2, Monoclonal Antibody HER2, Ogivri, Ontruzant, PF-05280014, rhuMAb HER2, RO0452317, Trastuzumab Biosimilar ABP 980, Trastuzumab Biosimilar ALT02, trastuzumab biosimilar EG12014, Trastuzumab Biosimilar HLX02, Trastuzumab Biosimilar PF-05280014, Trastuzumab-dkst, Trastuzumab-DTTB, Trastuzumab-pkrb, Trastuzumab-QYYP, Trazimera
Treatment (trastuzumab)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed endometrial adenocarcinoma
  • Advanced, recurrent, or persistent disease
  • Refractory to curative therapy
  • HER2/neu gene amplification by fluorescent in situ hybridization
  • Measurable disease
  • Previously irradiated field as sole site of measurable disease allowed if evidence of progression since completion of radiotherapy
  • Performance status - GOG 0-2
  • Absolute neutrophil count ? 1,500/mm\^3
  • Platelet count ? 100,000/mm\^3
  • Bilirubin ? 1.5 times upper limit of normal (ULN)
  • Creatinine ? 1.5 times ULN
  • LVEF ? 45% by echocardiogram or MUGA
  • History of coronary artery disease and/or congestive heart failure allowed if medical management of condition has been stable within the past 6 months
  • No active or unstable cardiac disease
  • No active angina
  • +25 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gynecologic Oncology Group

Philadelphia, Pennsylvania, 19103, United States

Location

MeSH Terms

Interventions

TrastuzumabPF-05280014OgivriOntruzanttrastuzumab biosimilar HLX02

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Gini F Fleming

    Gynecologic Oncology Group

    PRINCIPAL INVESTIGATOR

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

August 3, 2000

First Posted

January 27, 2003

Study Start

September 18, 2000

Primary Completion

September 4, 2007

Study Completion

January 31, 2010

Last Updated

July 31, 2019

Record last verified: 2019-07

Locations

US(1)