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Gemcitabine and Cisplatin for Advanced or Recurrent Endometrial Cancer

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ClinicalTrials.gov Identifier: NCT00388154
Recruitment Status : Completed
First Posted : October 16, 2006
Results First Posted : November 13, 2014
Last Update Posted : November 13, 2014
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Tracking Information
First Submitted Date  ICMJE October 12, 2006
First Posted Date  ICMJE October 16, 2006
Results First Submitted Date  ICMJE November 5, 2014
Results First Posted Date  ICMJE November 13, 2014
Last Update Posted Date November 13, 2014
Study Start Date  ICMJE August 2004
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 12, 2014)
  • Participant Responses [ Time Frame: Responses required confirmation by imaging after 4-week+ interval following 3 week (21 day) therapy course. ]
    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. ]
    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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Gemcitabine and Cisplatin for Advanced or Recurrent Endometrial Cancer
Official Title  ICMJE A Phase II Study of Gemcitabine and Cisplatin for Advanced or Recurrent Endometrial Cancer
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Endometrial Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.
Interventions:
  • Drug: Gemcitabine
  • Drug: Cisplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 8, 2013)
21
Original Enrollment  ICMJE
 (submitted: October 12, 2006)
35
Actual Study Completion Date  ICMJE November 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00388154
Other Study ID Numbers  ICMJE 2003-0823
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor  ICMJE M.D. Anderson Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jubilee Brown, MD M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP