Clinical trial · Interventional
Trastuzumab in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer
A Phase II Evaluation of Trastuzumab (MoAb HER2) in Patients With Advanced, Recurrent or Persistent Endometrial Carcinoma With or Without Prior Chemotherapy
NCT00006089CI-TRIAL-00039833completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Adenocarcinoma | Endometrial Adenocarcinoma | CURATED_BROADER | 0.80 |
| ERBB2 Gene Amplification | — | UNRESOLVED | — |
| Recurrent Uterine Corpus Carcinoma | — | UNRESOLVED | — |
| Stage III Uterine Corpus Cancer AJCC v7 | Malignant Uterine Corpus Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Uterine Corpus Cancer AJCC v7 | Malignant Uterine Corpus Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Trastuzumab | Biological | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (trastuzumab)
- description
- 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.
- interventionNames
- Other: Laboratory Biomarker Analysis
- Biological: Trastuzumab
Primary outcomes (2)
- measure
- Frequency and duration of objective response
- timeFrame
- Up to 5 years
- measure
- Frequency and severity of observed adverse effects assessed using Common Terminology Criteria (CTC) version 2.0
- timeFrame
- Up to 5 years
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * 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
References
Publications (0)
Data not yet available
No reference posted for this study.