A Phase II Study of Gemcitabine and Cisplatin for Advanced or Recurrent Endometrial Cancer
N/A
N/A
Female
Endometrial Cancer
Trial Information
A Phase II Study of Gemcitabine and Cisplatin for Advanced or Recurrent Endometrial Cancer
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.
Inclusion Criteria:
1. Patients 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 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 limit of normal, and Bilirubin
5. Neuropathy (sensory and motor) should be less than or equal to 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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Objective Response Rate (CR + PR)
Outcome Time Frame:
21-day Cycle Assessments or until either disease progression or adverse effects prohibit further treatment.
Safety Issue:
Yes
Principal Investigator
Jubilee Brown, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
2003-0823
NCT ID:
NCT00388154
Start Date:
August 2004
Completion Date:
Related Keywords:
- Endometrial Cancer
- Endometrial Cancer
- Gemcitabine
- Gemzar
- Gemcitabine Hydrochloride
- Cisplatin
- Platinol-AQ
- Platinol
- CDDP
- Endometrial Neoplasms
- Sarcoma, Endometrial Stromal
- Adenoma
Name | Location |
|---|---|
| UT MD Anderson Cancer Center | Houston, Texas 77030 |
| St. Lukes Episcopal Hospital | Houston, Texas 77030 |
| The Woman's Hospital of Texas | Houston, Texas 77054 |
