Evaluation of Carboplatin/Paclitaxel With and Without Trastuzumab (Herceptin) in Uterine Serous Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Yale University
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01367002
First received: May 26, 2011
Last updated: October 10, 2014
Last verified: October 2014

May 26, 2011
October 10, 2014
June 2011
July 2015   (final data collection date for primary outcome measure)
Progression free survival differences between Arm A versus Arm B. [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
Progression free survival differences between Arm A versus Arm B.
Same as current
Complete list of historical versions of study NCT01367002 on ClinicalTrials.gov Archive Site
To assess the safety profile of trastuzumab in USPC patients by CTCAE v4.0 [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
To assess the safety profile of trastuzumab in USPC patients by CTCAE v4.0.
Same as current
Not Provided
Not Provided
 
Evaluation of Carboplatin/Paclitaxel With and Without Trastuzumab (Herceptin) in Uterine Serous Cancer
Randomized Phase II Evaluation of Carboplatin/Paclitaxel With and Without Trastuzumab (Herceptin) in HER2/Neu+ Patients With Advance/Recurrent Uterine Serous Papillary Carcinoma

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).

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Endometrial Cancer
  • 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:
    • Taxus brevifolia
    • cis-Diammine
  • 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
  • Active Comparator: Carboplatin/Paclitaxel
    Chemotherapy
    Intervention: Drug: Carboplatin/Paclitaxel
  • Experimental: Trastuzumab
    Monoclonal antibody
    Intervention: Drug: Trastuzumab

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
July 2015
July 2015   (final data collection date for primary outcome measure)

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.
Female
Not Provided
No
Contact: Alessandro D Santin, M.D. 203-737-4450 alessandro.santin@yale.edu
Contact: Martha Luther, R.N. 203-737-2781 martha.luther@yale.edu
United States
 
NCT01367002
1012007786
No
Yale University
Yale University
Genentech, Inc.
Principal Investigator: Alessandro D Santin, M.D. Yale University
Yale University
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP