Clinical trial NCT00388154: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Endometrial Cancer
Keywords: Endometrial Cancer
Gemcitabine
Gemzar
Gemcitabine Hydrochloride
Cisplatin
Platinol-AQ
Platinol
CDDP
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2006-10-16
Enrollment: 21
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 \</= 1.5 mg/dL serum glutamate pyruvate transaminase (SGPT/ALT) \</= 3 times upper limit of normal, and Bilirubin \</= 1.5 times 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.

Primary outcomes:
measure: Participant Responses
timeFrame: Responses required confirmation by imaging after 4-week+ interval following 3 week (21 day) therapy course.
measure: Overall Objective Response Rate (CR + PR)
timeFrame: Responses required confirmation by imaging after 4-week+ interval following 3 week (21 day) therapy course.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: St. Lukes Episcopal Hospital
state: Texas
city: Houston
country: United States
facility: UT MD Anderson Cancer Center
state: Texas
city: Houston
country: United States
facility: The Woman's Hospital of Texas
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Jubilee Brown, MD
role: PRINCIPAL_INVESTIGATOR
References: