Gemcitabine and Cisplatin for Advanced or Recurrent Endometrial Cancer
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Endometrial Cancer |
Drug: Gemcitabine Drug: Cisplatin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Gemcitabine and Cisplatin for Advanced or Recurrent Endometrial Cancer |
- Objective Response Rate (CR + PR) [ Time Frame: 21-day Cycle Assessments or until either disease progression or adverse effects prohibit further treatment. ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 35 |
| Study Start Date: | August 2004 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Gemcitabine + Cisplatin
Gemcitabine 900 mg/m^2 by vein 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.
|
Drug: Gemcitabine
900 mg/m^2 by vein over 1 hour on Day 1 and Day 8.
Other Names:
Drug: Cisplatin
30 mg/m^2 by vein over 1 hour on Day 1 and Day 8.
Other Names:
|
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| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
- 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.
- 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.
- 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.
- Patients must have a Zubrod Performance Status of 0, 1, or 2.
- Patients must have signed an approved informed consent.
- Patients must have recovered from effects of recent surgery or radiotherapy. They should be free of significant infection.
Exclusion Criteria:
- Patients previously treated with gemcitabine.
- Patients with a concomitant malignancy, other than non-melanoma skin cancer.
- Patients with papillary serous or clear cell carcinoma of the endometrium, or patients with malignant mixed mullerian tumor of the uterus.
- Patients with a prior malignancy who have been disease-free for less than 5 years.
- 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.
- 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.
- Patients whose circumstances will not permit study completion or adequate follow-up.
- Patients who have no measurable disease.
- Patients with a life expectancy of less than 3 months.
Contacts and Locations| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| St. Lukes Episcopal Hospital | |
| Houston, Texas, United States, 77030 | |
| The Woman's Hospital of Texas | |
| Houston, Texas, United States, 77054 | |
| Principal Investigator: | Jubilee Brown, MD | M.D. Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00388154 History of Changes |
| Other Study ID Numbers: | 2003-0823 |
| Study First Received: | October 12, 2006 |
| Last Updated: | August 24, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Endometrial Cancer Gemcitabine Gemzar Gemcitabine Hydrochloride |
Cisplatin Platinol-AQ Platinol CDDP |
Additional relevant MeSH terms:
|
Endometrial Neoplasms Sarcoma, Endometrial Stromal Adenoma Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Diseases Genital Diseases, Female Neoplasms, Complex and Mixed Neoplasms by Histologic Type Sarcoma Neoplasms, Connective and Soft Tissue Endometrial Stromal Tumors |
Neoplasms, Glandular and Epithelial Gemcitabine Cisplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents |
ClinicalTrials.gov processed this record on June 18, 2013