Gemcitabine and Cisplatin for Advanced or Recurrent Endometrial Cancer

Brief Title

Gemcitabine and Cisplatin for Advanced or Recurrent Endometrial Cancer

Official Title

A Phase II Study of Gemcitabine and Cisplatin for Advanced or Recurrent Endometrial Cancer

Brief 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.

Detailed Description

Gemcitabine and cisplatin are drugs that are used in the treatment of many types of cancer.
Each acts to kill cancer cells throughout the body.

Before treatment starts, you will have a complete physical exam, pelvic exam, blood tests
(about 2-3 teaspoons), a chest x-ray, and a CT scan or MRI. Women able to have children must
have a negative blood pregnancy test.

On Day 1 and Day 8, you will receive gemcitabine chemotherapy through a small tube placed in
a vein over 1 hour. This will be followed by cisplatin chemotherapy given by vein over 1
hour. Before chemotherapy is given, you will receive medications to prevent nausea. You will
not receive any therapy on Day 15. One course of therapy is 3 weeks long.

Routine blood tests (about 1 teaspoon) will be done weekly during treatment and before each
course of therapy (every 3 weeks). A complete checkup, including a history and physical exam,
pelvic exam, and routine blood tests (about 2-3 teaspoons) will also be done before each
course of therapy and a month after treatment ends. CT or MRI scans will be repeated every 2
to 3 cycles and at the end of treatment. Participants who have a partial or complete response
(the tumor shrinks by more than 50% or disappears completely) will have the CT or MRI
repeated at least 4 weeks later to confirm the response.

You may continue to receive treatment as long as your disease remains stable or improves.
Participants who experience significant side effects may be allowed to drop to a lower dose
if their disease is not worse. If the disease gets worse or if intolerable side effects
occur, you will be taken off study.

When you are taken off the study, a complete medical history and physical exam will be
performed. Routine blood tests (about 2-3 teaspoons) will be performed. Any side effects will
be monitored until they go away.

This is an investigational study. Both of the study drugs are FDA approved and commercially
available, though their use together in this study is investigational. Up to 35 patients will
take part in this study. Patients will be enrolled at M.D. Anderson, St. Lukes Episcopal
Hospital and The Woman's Hospital of Texas.

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Participant Responses

Condition

Endometrial Cancer

Intervention

Gemcitabine

Study Arms / Comparison Groups

 Gemcitabine + Cisplatin

Description:  Gemcitabine 900 mg/m^2 by vein (IV) over 1 hour on Day 1 and Day 8. Cisplatin 30 mg/m^2 by vein over 1 hour on Day 1 and Day 8.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

August 2004

Completion Date

November 2013

Primary Completion Date

November 2013

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

Gender

Female

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Jubilee Brown, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT00388154

Organization ID

2003-0823

Responsible Party

Sponsor

Study Sponsor

M.D. Anderson Cancer Center

Study Sponsor

Jubilee Brown, MD, Principal Investigator, M.D. Anderson Cancer Center

Verification Date

November 2014