Evaluation of Carboplatin/Paclitaxel With and Without Trastuzumab (Herceptin) in Uterine Serous Cancer
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ClinicalTrials.gov Identifier: NCT01367002 |
Recruitment Status :
Completed
First Posted : June 6, 2011
Results First Posted : April 18, 2023
Last Update Posted : May 17, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Endometrial Cancer | Drug: Carboplatin/Paclitaxel Drug: Trastuzumab | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 61 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | June 2011 |
Actual Primary Completion Date : | June 30, 2022 |
Actual Study Completion Date : | June 30, 2022 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Carboplatin/Paclitaxel
Chemotherapy
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Drug: Carboplatin/Paclitaxel
Paclitaxel 175 mg/m2 will administered intravenously every 21 days for 6 cycles. Carboplatin AUC 5 will be administered intravenously every 21 days for 6 cycles. 100% of patients will receive Carboplatin/Paclitaxel.
Other Names:
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Experimental: Trastuzumab
Monoclonal antibody
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Drug: Trastuzumab
Paclitaxel 175 mg/m2 will be administered intravenously every 21 days for 6 cycles. Carboplatin AUC 5 will be administered intravenously every 21 days for 6 cycles. On day 1, an 8 mg/kg loading dose of trastuzumab will be administered over a 90 minute period. Beginning on day 21, patients will receive 6mg/kg of trastuzumab, administered intravenously every 21 days and continued indefinitely every 21 days after 6 cycles of cytotoxic therapy are completed and until progression of the disease or prohibitive toxicities occur. 50% of patients will receive Carboplatin/Paclitaxel with the addition of Trastuzumab.
Other Name: Herceptin |
- Progression Free Survival Differences Between Treatment Arms. [ Time Frame: 6 years ]Progression free survival differences between treatment arms.
- To Assess the Safety Profile of Trastuzumab in USPC Patients by CTCAE v4.0 [ Time Frame: 6 years ]To assess the safety profile of trastuzumab in USPC patients by CTCAE v4.0. Presented are counts of those that experience any Serious Adverse Events or All Other Adverse Events.
- To Assess Objective Response Rate (ORR) [ Time Frame: 6 years ]To assess objective response rate (ORR)
- To Assess Overall Survival (OS) [ Time Frame: 6 years ]To assess overall survival (OS), presented are the number of participants that survived through the duration of the study period.

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01367002

Principal Investigator: | Alessandro D Santin, M.D. | Yale University |
Documents provided by Yale University:
Other Publications:
Responsible Party: | Yale University |
ClinicalTrials.gov Identifier: | NCT01367002 |
Other Study ID Numbers: |
1012007786 |
First Posted: | June 6, 2011 Key Record Dates |
Results First Posted: | April 18, 2023 |
Last Update Posted: | May 17, 2023 |
Last Verified: | May 2023 |
Uterine serous papillary carcinoma Type II endometrial cancer HER2/neu Paclitaxel, Carboplatin, Trastuzumab |
Endometrial Neoplasms 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 Paclitaxel Carboplatin Trastuzumab Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Immunological |