Gemcitabine and Cisplatin for Advanced or Recurrent Endometrial Cancer
Condition: Endometrial Cancer
MeSH terms: Endometrial Neoplasms
Intervention: Gemcitabine; Cisplatin
Intervention description: 900 mg/m^2 by vein over 1 hour on Day 1 and Day 8.; 30 mg/m^2 by vein over 1 hour on Day 1 and Day 8.
Intervention MeSH terms: Cisplatin; Gemcitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: Female
Healthy volunteers: No
Keywords: Endometrial Cancer; Gemcitabine; Gemzar; Gemcitabine Hydrochloride; Cisplatin; Platinol-AQ; Platinol; CDDP

Summary:

      Primary Objective:

        -  To estimate the antitumor activity of the combination of gemcitabine and cisplatin in
           patients with advanced (stage III or IV) or recurrent endometrial cancer.

      Secondary Objective:

        -  To determine the nature and degree of toxicity of the combination of gemcitabine and
           cisplatin in this cohort of patients.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients must have histologically documented primary International Federation of
             Gynecology and Obstetrics (FIGO) Stage III or IV or recurrent endometrial carcinoma
             whose potential for cure by radiation therapy or surgery alone or in combination is
             very poor. Pathologic documentation of the recurrence is required.

          2. Patients must have measurable disease as defined in section 8, under Criteria for
             Response. Disease in an irradiated field as the only site of measurable disease is
             acceptable only if there has been clear progression since completion of radiation
             treatment.

          3. Patients may have received an unlimited amount of prior therapy, including
             platinum-based therapy, but such therapies must be discontinued at least 3 weeks prior
             to entry on this study. At least two weeks must have elapsed from the completion of
             radiotherapy and the start of therapy and six weeks must have elapsed if the
             radiotherapy involved the whole pelvis or over 50% of the spine, provided the acute
             effects of radiation treatment have resolved. Hormonal therapy may be discontinued at
             any time prior to initiating the protocol.

          4. Patients must have adequate organ function as follows: Platelets >/= 100,000/ul;
             Granulocytes (ANC) >/= 1,500/ul; Creatinine </= 1.5 mg/dL serum glutamate pyruvate
             transaminase (SGPT/ALT) </= 3 times upper limit of normal, and Bilirubin </= 1.5 times
             the institutional upper limit of normal.

          5. Neuropathy (sensory and motor) should be less than or equal to Common Toxicity
             Criteria for Adverse Effects (CTCAE) grade 1.

          6. Patients must have a Zubrod Performance Status of 0, 1, or 2.

          7. Patients must have signed an approved informed consent.

          8. Patients must have recovered from effects of recent surgery or radiotherapy. They
             should be free of significant infection.

        Exclusion Criteria:

          1. Patients previously treated with gemcitabine.

          2. Patients with a concomitant malignancy, other than non-melanoma skin cancer.

          3. Patients with papillary serous or clear cell carcinoma of the endometrium, or patients
             with malignant mixed mullerian tumor of the uterus.

          4. Patients with a prior malignancy who have been disease-free for less than 5 years.

          5. Patients with concomitant medical illness such as serious uncontrolled infection,
             uncontrolled angina or serious peripheral neuropathy which, in the opinion of the
             treating physician, make the treatments prescribed on the study unreasonably hazardous
             for the patient.

          6. Patients with renal dysfunction, chronic or acute kidney disease, or renal failure
             which, in the opinion of the treating physician, would make the treatments prescribed
             on the study unreasonably hazardous for the patient.

          7. Patients whose circumstances will not permit study completion or adequate follow-up.

          8. Patients who have no measurable disease.

          9. Patients with a life expectancy of less than 3 months.