Endometrial AdenocarcinomaPhase 2NCT00006089
Trastuzumab in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer
A Phase 2 study testing Laboratory Biomarker Analysis and Trastuzumab in people with Endometrial Adenocarcinoma and ERBB2 Gene Amplification, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Adenocarcinoma, ERBB2 Gene Amplification, Recurrent Uterine Corpus Carcinoma
- What is being tested?
- Laboratory Biomarker Analysis and Trastuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2000to 31 Jan 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 40Show fewer
- 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
- No myocardial infarction within the past 6 months
- No requirement for supplemental oxygen at rest or with ambulation
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active infection requiring antibiotics
- No uncontrolled infection
- No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
- No other unstable medical condition that would preclude study participation
- At least 3 weeks since prior biologic and immunologic agents directed at the malignant tumor
- No prior anti-HER2 monoclonal antibody preparation
- No other concurrent immunotherapy
- Recovered from prior chemotherapy
- Multiple prior chemotherapy regimens allowed
- No more than 320 mg/m^2 total dose of prior doxorubicin allowed (including doxorubicin HCl liposome or other liposomally encapsulated doxorubicin preparations)
- No concurrent chemotherapy
- At least 1 week since prior hormonal therapy directed at the malignant tumor
- No concurrent hormonal therapy
- Continuation of hormone replacement therapy allowed
- See Disease Characteristics
- At least 3 weeks since prior radiotherapy for the malignant tumor and recovered
- No concurrent radiotherapy
- Recovered from prior recent surgery
- At least 3 weeks since any prior therapy directed at the malignant tumor
- No prior cancer treatment that would contraindicate study therapy
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Gynecologic Oncology Group
Philadelphia, Pennsylvania, 19103
About this study
Official title: A Phase II Evaluation of Trastuzumab (MoAb HER2) in Patients With Advanced, Recurrent or Persistent Endometrial Carcinoma With or Without Prior Chemotherapy
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.
Read the detailed description
PRIMARY OOBJECTIVES:
- Determine the antitumor activity of trastuzumab (Herceptin), in terms of response, in patients with advanced, recurrent, or persistent endometrial adenocarcinoma that demonstrates HER2/neu gene amplification by fluorescent in situ hybridization.
II. Determine the toxicity of this regimen in these patients.
SECONDARY OBJECTIVES:
- Determine the progression-free and overall survival of patients treated with this regimen.
II. Determine the effects of prognostic factors (i.e., initial performance status and histological grade) in patients treated with this regimen.
OUTLINE: This is an open-label, multicenter study.
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.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 25-42 patients will be accrued for this study within 12 years.
- Conditions
- Endometrial Adenocarcinoma, ERBB2 Gene Amplification, Recurrent Uterine Corpus Carcinoma, Stage III Uterine Corpus Cancer AJCC v7, Stage IV Uterine Corpus Cancer AJCC v7
- Being tested
- Laboratory Biomarker Analysis, Trastuzumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory Biomarker AnalysisOther
Correlative studies
TrastuzumabBiological
Also called ABP 980, ALT02, Anti-c-ERB-2, Anti-c-erbB2 Monoclonal Antibody
Given IV
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Laboratory Biomarker Analysis; Biological: Trastuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and duration of objective response
Measured: Up to 5 years
Frequency and severity of observed adverse effects assessed using Common Terminology Criteria (CTC) version 2.0
Measured: Up to 5 years
Secondary outcomes (3)
Duration of progression-free survival
Will be evaluated with non-parametric statistics (such as the log-rank test) through comparisons with the historical controls.
Measured: From study entry until disease progression, death or date or last contact, assessed up to 5 years
Duration of overall survival
Will be evaluated with non-parametric statistics (such as the log-rank test) through comparisons with the historical controls.
Measured: 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)
Comparisons will be made through a Cox model, which allows for adjustments with the prognostic variables.
Measured: Not Provided
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study start18 Sep 2000
- Primary completion4 Sep 2007
- Study completion31 Jan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Gynecologic Oncology Group
- Responsible party
- Sponsor
- Investigators
- Gini F Fleming, Principal investigator, Gynecologic Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006089
- Sponsor's protocol ID
- NCI-2012-02356
- Other IDs
- NCI-2012-02356, CDR0000068091, GOG-0181B, GOG-0181-B, GOG-0181B, U10CA027469
- Status last verified
- Jul 2019
- First submitted
- 3 Aug 2000
- Last updated
- 31 Jul 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Evaluation of Trastuzumab (MoAb HER2) in Patients With Advanced, Recurrent or Persistent Endometrial Carcinoma With or Without Prior Chemotherapy
- ClinicalTrials.gov ID
- NCT00006089
- Acronym / sponsor ID
- NCI-2012-02356
- Conditions
- Endometrial Adenocarcinoma, ERBB2 Gene Amplification, Recurrent Uterine Corpus Carcinoma, Stage III Uterine Corpus Cancer AJCC v7, Stage IV Uterine Corpus Cancer AJCC v7
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Collaborators
- Gynecologic Oncology Group
- Study start
- 18 Sep 2000 (actual)
- Primary completion
- 4 Sep 2007 (actual)
- Study completion
- 31 Jan 2010 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OOBJECTIVES:
- Determine the antitumor activity of trastuzumab (Herceptin), in terms of response, in patients with advanced, recurrent, or persistent endometrial adenocarcinoma that demonstrates HER2/neu gene amplification by fluorescent in situ hybridization.
II. Determine the toxicity of this regimen in these patients.
SECONDARY OBJECTIVES:
- Determine the progression-free and overall survival of patients treated with this regimen.
II. Determine the effects of prognostic factors (i.e., initial performance status and histological grade) in patients treated with this regimen.
OUTLINE: This is an open-label, multicenter study.
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.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 25-42 patients will be accrued for this study within 12 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (trastuzumab) | Experimental | Other: Laboratory Biomarker Analysis, Biological: TrastuzumabPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (40 listed)
- Histologically confirmed endometrial adenocarcinoma
- HER2/neu gene amplification by fluorescent in situ hybridization
- Measurable disease
- Performance status - GOG 0-2
- Absolute neutrophil count ? 1,500/mm^3
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laboratory Biomarker AnalysisCorrelative studies | Other | Treatment (trastuzumab) |
| TrastuzumabAlso: ABP 980, ALT02, Anti-c-ERB-2, Anti-c-erbB2 Monoclonal AntibodyGiven IV | Biological | Treatment (trastuzumab) |
Primary outcome
Frequency and duration of objective response
Time frame: Up to 5 years
Frequency and severity of observed adverse effects assessed using Common Terminology Criteria (CTC) version 2.0
Time frame: Up to 5 years
3 secondary outcomes
Duration of progression-free survival
Time frame: From study entry until disease progression, death or date or last contact, assessed up to 5 years
Duration of overall survival
Time frame: 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)
Time frame: Not Provided
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gini F Fleming principal investigator
Gynecologic Oncology Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Laboratory Biomarker Analysis and Trastuzumab in people with Endometrial Adenocarcinoma and ERBB2 Gene Amplification, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 40 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency and duration of objective response (time frame: Up to 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2019; AzTrials last refreshed its copy on 7 Nov 2026.