Gemcitabine and Cisplatin for Advanced or Recurrent Endometrial Cancer
A Phase II Study of Gemcitabine and Cisplatin for Advanced or Recurrent Endometrial Cancer
1 other identifier
interventional
21
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Aug 2004
Longer than P75 for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2004
CompletedFirst Submitted
Initial submission to the registry
October 12, 2006
CompletedFirst Posted
Study publicly available on registry
October 16, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedResults Posted
Study results publicly available
November 13, 2014
CompletedNovember 13, 2014
November 1, 2014
9.3 years
October 12, 2006
November 5, 2014
November 12, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
Responses required confirmation by imaging after 4-week+ interval following 3 week (21 day) therapy course.
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.
Responses required confirmation by imaging after 4-week+ interval following 3 week (21 day) therapy course.
Study Arms (1)
Gemcitabine + Cisplatin
EXPERIMENTALGemcitabine 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
900 mg/m\^2 by vein over 1 hour on Day 1 and Day 8.
30 mg/m\^2 by vein over 1 hour on Day 1 and Day 8.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
St. Lukes Episcopal Hospital
Houston, Texas, 77030, United States
UT MD Anderson Cancer Center
Houston, Texas, 77030, United States
The Woman's Hospital of Texas
Houston, Texas, 77054, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jubilee Brown, MD/Associate Professor, Gynecology Oncology & Reproductive Medicine
- Organization
- University of Texas (UT) MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Jubilee Brown, MD
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 12, 2006
First Posted
October 16, 2006
Study Start
August 1, 2004
Primary Completion
November 1, 2013
Study Completion
November 1, 2013
Last Updated
November 13, 2014
Results First Posted
November 13, 2014
Record last verified: 2014-11