Gemcitabine and Cisplatin for Advanced or Recurrent Endometrial Cancer

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Cisplatin; Gemcitabine

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; Creatininetransaminase (SGPT/ALT)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.