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
21
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