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Gemcitabine and Cisplatin for Advanced or Recurrent Endometrial Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00388154
First received: October 12, 2006
Last updated: November 12, 2014
Last verified: November 2014
  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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Participant Responses [ Time Frame: Responses required confirmation by imaging after 4-week+ interval following 3 week (21 day) therapy course. ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: Responses required confirmation by imaging after 4-week+ interval following 3 week (21 day) therapy course. ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 21
Study Start Date: August 2004
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gemcitabine + Cisplatin
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.
Drug: Gemcitabine
900 mg/m^2 by vein over 1 hour on Day 1 and Day 8.
Other Names:
  • Gemzar
  • Gemcitabine Hydrochloride
Drug: Cisplatin
30 mg/m^2 by vein over 1 hour on Day 1 and Day 8.
Other Names:
  • Platinol-AQ
  • Platinol
  • CDDP

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
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00388154

Locations
United States, Texas
St. Lukes Episcopal Hospital
Houston, Texas, United States, 77030
The Woman's Hospital of Texas
Houston, Texas, United States, 77054
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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
Results First Received: November 5, 2014
Last Updated: November 12, 2014
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
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Site
Urogenital Neoplasms
Uterine Diseases
Uterine Neoplasms
Cisplatin
Gemcitabine
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014