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Study Summary
No. 2003-0823:.......Endometrial......Jubilee Brown......Gynecologic Oncology
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Study Summary Title
Study Summary
Number:
2003-0823
Study Title:A Phase II Study of Gemcitabine and Cisplatin for Advanced or Recurrent Endometrial Cancer
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Physician New Patient Referral
Name:Jubilee BrownPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Gynecologic OncologyReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-745-8837
Contact us about clinical trials
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General Information
Disease Group:EndometrialSupported By:N/A
Phase of Study:Phase IIReturn
Visit:
Patients will be seen for chemotherapy clearance every 21 days with 3 days
flexibility from the planned day of treatment.

Treatment may be delayed for one week for special events such as funeral,
vacation, holiday, and other family/personal events.
Treatment
Agents:
Cisplatin
Gemcitabine
Home Care:None
Treatment Loc:Independent Multicenter Arrangements
Estimated
Length of Stay
in Houston:
No hospitalization anticipated.
Description/
Intervention:
The goal of this clinical research study is to find out if the combination of
gemcitabine and cisplatin will help to shrink or slow the growth of tumors in
patients with advanced (stage III or IV) or recurrent endometrial cancer. The
safety of this drug combination will also be studied.
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Study Objectives / Outcomes
    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.
+Objectives:
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Study Status Information
Study Activation / Registration Date:08/20/2004
IRB Review and Approval Date:03/03/2004
Study Type:Therapeutic
Recruitment Status:Closed
Projected Accrual:20
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) Pts must have histologically documented primary 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 unlimited number 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 SGPT (ALT) </= 3x upper limit of normal, and Bilirubin </= 1.5 times the institutional upper limit of normal. Neuropathy (sensory and motor) should be less than or equal to CTCAE grade 1.

5) Patients must have a Zubrod Performance Status of 0, 1, or 2.

6) Patients must have signed an approved informed consent.

7) 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.

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Links
Registration Number: NCT00388154
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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