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Gemcitabine and Cisplatin for Advanced or Recurrent Endometrial Cancer

Primary Purpose

Endometrial Cancer

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Gemcitabine

Cisplatin

About this trial

This is an interventional treatment trial for Endometrial Cancer focused on measuring Endometrial Cancer, Gemcitabine, Gemzar, Gemcitabine Hydrochloride, Cisplatin, Platinol-AQ, Platinol, CDDP

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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.
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 serum glutamate pyruvate transaminase (SGPT/ALT) </= 3 times 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 Common Toxicity Criteria for Adverse Effects (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.

Sites / Locations

St. Lukes Episcopal Hospital
UT MD Anderson Cancer Center
The Woman's Hospital of Texas

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gemcitabine + Cisplatin

Arm 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.

Outcomes

Primary Outcome Measures

Participant Responses

Response Evaluation Criteria In Solid Tumors (RECIST): Complete Response (CR): disappearance all target & nontarget lesions, absence new lesions, documented by 2 disease assessments 4 weeks apart; Partial response (PR): 30% decrease in sum longest diameter (LD) all measurable target lesions (baseline sum LDs as reference) & absence of progression of nontarget lesions or development of new, documented by 2 disease assessments 4 weeks apart. When only target lesion solitary pelvic mass measurable by physical examination but not radiography, a 50% decrease in LD required to be PR; Progressive disease (PD): 20% increase in sum LDs of target lesions (reference smallest sum of LDs at any assessment) or appearance of new lesions within 9 weeks of study entry, and unequivocal progression of existing nontarget lesions, other than pleural effusions without cytological proof of neoplastic origin within 9 weeks of enrollment; Stable disease (SD): any condition not meeting above CR, PR, or PD.

Overall Objective Response Rate (CR + PR)

Objective response (OR) defined as percentage of participants with RECIST Complete Response (CR) and Partial Response (PR), defined as CR: Disappearance all target and non-target lesions, no evidence of new lesions documented by 2 disease assessments at least 4 weeks apart. Normalization of CA-125, if elevated at baseline, is required; PR: 30% decrease in sum of longest dimensions (LD) of all target measurable lesions reference baseline sum of LD, no unequivocal progression of non-target lesions; no new lesions documented by 2 disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical examination, which is not radiographically measurable, a 50% decrease in the LD is required. 21-day cycle assessments or until either disease progression or adverse effects prohibit further treatment.

Secondary Outcome Measures

Full Information

NCT ID

NCT00388154

First Posted

October 12, 2006

Last Updated

November 12, 2014

Sponsor

M.D. Anderson Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT00388154

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Completed

Study Start Date

August 2004 (undefined)

Primary Completion Date

November 2013 (Actual)

Study Completion Date

November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

M.D. Anderson Cancer Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Endometrial Cancer

Keywords

Endometrial Cancer, Gemcitabine, Gemzar, Gemcitabine Hydrochloride, Cisplatin, Platinol-AQ, Platinol, CDDP

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Gemcitabine + Cisplatin

Arm Type

Experimental

Arm 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.

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Other Intervention Name(s)

Gemzar, Gemcitabine Hydrochloride

Intervention Description

900 mg/m^2 by vein over 1 hour on Day 1 and Day 8.

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Other Intervention Name(s)

Platinol-AQ, Platinol, CDDP

Intervention Description

30 mg/m^2 by vein over 1 hour on Day 1 and Day 8.

Primary Outcome Measure Information:

Title

Participant Responses

Description

Time Frame

Responses required confirmation by imaging after 4-week+ interval following 3 week (21 day) therapy course.

Title

Overall Objective Response Rate (CR + PR)

Description

Time Frame

Responses required confirmation by imaging after 4-week+ interval following 3 week (21 day) therapy course.

10. Eligibility

Sex

Female

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. 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 serum glutamate pyruvate transaminase (SGPT/ALT) </= 3 times 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 Common Toxicity Criteria for Adverse Effects (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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jubilee Brown, MD

Organizational Affiliation

M.D. Anderson Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

St. Lukes Episcopal Hospital

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

UT MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

The Woman's Hospital of Texas

City

Houston

State/Province

Texas

ZIP/Postal Code

77054

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.mdanderson.org

Description

University of Texas MD Anderson Cancer Center Website

Learn more about this trial

Gemcitabine and Cisplatin for Advanced or Recurrent Endometrial Cancer

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