Gemcitabine in Treating Patients With Recurrent or Persistent Endometrial Cancer
Condition: Endometrial Adenocarcinoma; Endometrial Adenosquamous Carcinoma; Endometrial Clear Cell Adenocarcinoma; Recurrent Uterine Corpus Carcinoma
MeSH terms: Carcinoma; Adenocarcinoma; Adenocarcinoma, Clear Cell; Carcinoma, Adenosquamous; Recurrence
Intervention: Gemcitabine Hydrochloride
Intervention description: Given IV
Intervention MeSH terms: Gemcitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying the side effects of gemcitabine and to see how well it works
      in treating patients with recurrent or persistent endometrial cancer. Drugs used in
      chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells,
      either by killing the cells or by stopping them from dividing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed endometrial adenocarcinoma

               -  Recurrent or persistent disease

               -  Refractory to curative therapy or established treatments

          -  The following epithelial cell types are eligible:

               -  Endometrioid adenocarcinoma

               -  Serous adenocarcinoma

               -  Undifferentiated carcinoma

               -  Clear cell adenocarcinoma

               -  Mixed epithelial carcinoma

               -  Adenocarcinoma not otherwise specified

               -  Mucinous adenocarcinoma

               -  Squamous cell carcinoma

               -  Transitional cell carcinoma

               -  Mesonephric carcinoma

          -  Measurable disease, defined as ≥1 lesion that can be accurately measured in ≥ 1
             dimension as ≥ 20 mm by conventional techniques, including palpation, plain x-ray, CT
             scan, or MRI OR as ≥ 10 mm by spiral CT scan

          -  Must have ≥ 1 target lesion

               -  Tumors within a previously irradiated field are designated as target lesions
                  provided there is documented disease progression or biopsy confirmed persistent
                  disease ≥ 90 days after completion of radiotherapy

          -  Must have received 1 prior chemotherapeutic regimen for management of endometrial
             cancer

               -  Initial treatment may have included non-cytotoxic agents or high-dose therapy,
                  consolidation therapy, or extended therapy administered after surgical or
                  non-surgical assessment

                    -  No more than one prior cytotoxic chemotherapy regimen (either with single or
                       combination cytotoxic drug therapy)

                         -  One additional non-cytotoxic regimen for management of recurrent or
                            persistent disease is allowed

          -  Not eligible for a higher priority GOG protocol, if one exists (i.e., any active Phase
             III GOG protocol for the same patient population)

          -  GOG performance status 0-2

          -  ANC ≥ 1,500/mm³

          -  Platelet count ≥ 100,000/mm³

          -  Creatinine ≤ 1.5 times upper limit of normal (ULN)

          -  Bilirubin ≤ 1.5 times ULN

          -  AST and ALT ≤ 2.5 times ULN

          -  Alkaline phosphatase ≤ 2.5 times ULN

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for ≥ 3 months after
             completion of study treatment

          -  No neuropathy (sensory and motor) > grade 1, according to NCI CTCAE v3.0

          -  No active infection requiring antibiotics (except an uncomplicated urinary tract
             infection)

          -  No other invasive malignancies within the past 5 years except non-melanoma skin cancer

          -  No prior cancer treatment that contraindicates study therapy

          -  Recovered from prior surgery, radiotherapy, or chemotherapy

          -  At least 1 week since prior hormonal therapy for endometrial cancer

          -  At least 3 weeks since prior biological therapy, immunotherapy, or other therapy for
             endometrial cancer

          -  At least 4 weeks since prior radiotherapy

          -  More than 3 years since prior radiotherapy for localized breast cancer, head and neck
             cancer, or skin cancer and

               -  No recurrent or persistent breast cancer, head and neck cancer, or skin cancer

          -  More than 3 years since prior adjuvant chemotherapy for localized breast cancer

               -  No recurrent or metastatic breast cancer

          -  No prior radiotherapy to any portion of the abdominal cavity or pelvis except for the
             treatment of endometrial cancer

          -  No prior chemotherapy for any abdominal or pelvic tumor except for the treatment of
             endometrial cancer

          -  No prior gemcitabine hydrochloride