Description:
The primary objective of this study is to estimate whether the addition of trastuzumab to
paclitaxel and carboplatin chemotherapy improves progression free survival when compared to
paclitaxel and carboplatin alone in Uterine Serous Papillary Carcinoma (USPC) patients
overexpressing Her2/neu at 3+ level by immunohistochemistry (IHC)or positive by fluorescence
in situ hybridization (FISH).
Title
- Brief Title: Evaluation of Carboplatin/Paclitaxel With and Without Trastuzumab (Herceptin) in Uterine Serous Cancer
- Official Title: Randomized Phase II Evaluation of Carboplatin/Paclitaxel With and Without Trastuzumab (Herceptin) in HER2/Neu+ Patients With Advance/Recurrent Uterine Serous Papillary Carcinoma
Clinical Trial IDs
- ORG STUDY ID:
1012007786
- NCT ID:
NCT01367002
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| Carboplatin/Paclitaxel | Taxus brevifolia, cis-Diammine | Carboplatin/Paclitaxel |
| Trastuzumab | Herceptin | Trastuzumab |
Purpose
The primary objective of this study is to estimate whether the addition of trastuzumab to
paclitaxel and carboplatin chemotherapy improves progression free survival when compared to
paclitaxel and carboplatin alone in Uterine Serous Papillary Carcinoma (USPC) patients
overexpressing Her2/neu at 3+ level by immunohistochemistry (IHC)or positive by fluorescence
in situ hybridization (FISH).
Detailed Description
The purpose of this study is to perform a randomized Phase II evaluation of
Carboplatin/Paclitaxel with or without Trastuzumab (Herceptin) in patients with HER2/neu+
advanced stage/recurrent disease with an emphasis on determining the progression free
survival in USPC patients and assessing immunologic markers predictive of trastuzumab
response.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Carboplatin/Paclitaxel | Active Comparator | Chemotherapy | |
| Trastuzumab | Experimental | Monoclonal antibody | |
Eligibility Criteria
Inclusion Criteria:
- Patients must have advanced (stage III-IV) or recurrent histologically confirmed USPC
with measurable disease.
- Patients must harbor a tumor HER2/neu+ based upon IHC staining score of 3+ or 2+ with
confirmed gene amplification by FISH
Exclusion Criteria:
- Patients with a history of other invasive malignancies, with the exception of
non-melanoma skin cancers, significant history of cardiac disease, uncontrolled
hypertension, unstable medical issue, brain leptomeningeal, prior therapy with
trastuzumab, uncontrolled seizure disorder, seropositive for HIV, active hepatitis,
hemorrhagic diathesis or requiring supplemental oxygen.
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | N/A |
| Eligible Gender: | Female |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Progression free survival differences between Arm A versus Arm B. |
| Time Frame: | 6 years |
| Safety Issue: | |
| Description: | Progression free survival differences between Arm A versus Arm B. |
Secondary Outcome Measures
| Measure: | To assess the safety profile of trastuzumab in USPC patients by CTCAE v4.0 |
| Time Frame: | 6 years |
| Safety Issue: | |
| Description: | To assess the safety profile of trastuzumab in USPC patients by CTCAE v4.0. |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Active, not recruiting |
| Lead Sponsor: | Yale University |
Trial Keywords
- Uterine serous papillary carcinoma
- Type II endometrial cancer
- HER2/neu
- Paclitaxel, Carboplatin, Trastuzumab
Last Updated
November 3, 2020
