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A Phase II Trial of Carboplatin/Paclitaxel with and without Trastuzumab in HER2/neu+ Patients with Advanced orRecurrent Uterine Serous Papillary Cancer

Conditions

Corpus Uteri

Trial Phase

Phase II

Trial Purpose and Description

Trial Purpose

To estimate whether the addition of trastuzumab to paclitaxel and carboplatin chemotherapy improves progression free survival (PFS) when compared to paclitaxel and carboplatin alone in USPC patients overexpressing HER2/neu at 3+ level by IHC or positive by FISH.


Participation Guidelines

Age:
Gender:

Eligibility Criteria

Inclusion Criteria:

  • Only recurrent patients with measurable lesions will be enrolled in the study.
  • Complete Response (CR): Disappearance of all target lesions. No new lesions. Lymph nodes must be <10mm short axis.
  • Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameters. No new lesions.
  • Progressive Disease (PD): The appearance of a new lesion, or at least a 20% increase in the sum of the longest diameters of the target lesions, taking as the reference the smallest sum of the longest diameters recorded since treatment started, and at least 5mm increase.
  • Stable Disease (SD): Target lesions do not qualify for CR, PR, or progression. No new lesions.

Exclusion Criteria:

  • Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancers are excluded if there is any evidence of other malignancy being present within the last five years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
  • Patients who have a significant history of cardiac disease, i.e., uncontrolled hypertension, unstable angina, uncontrolled congestive heart failure, or uncontrolled arrhythmias within 6 months of registration (NYHA classification III-IV).
  • Patients with any unstable medical issue (including cardiac issues as above, active treatment for pulmonary embolism, CVA, renal or hepatic insufficiency, active infection/sepsis requiring IV antibiotics).
  • Known brain/leptomengial involvement of the disease, active neurological disease, dementia.
  • Patients who have received prior therapy with trastuzumab or any other anti-epidermal growth factor type II receptor antibody.
  • Patients who have an uncontrolled seizure disorder, or active neurological disease.
  • Patients known to be seropositive for HIV and active hepatitis, even if liver function studies are in the eligible range.
  • Known hemorrhagic diathesis or active bleeding disorder.
  • Patients requiring supplemental oxygen.
Sponsor:
Yale Cancer Center
Dates:
05/06/2013
Last Updated:
Study HIC#:
1012007786