Efficacy Study of Weekly Taxotere and Topotecan for Recurrent Gynecologic (GYN) Cancers
Phase II Trial- Weekly Taxotere and Topotecan for Recurrent Ovarian, Primary Peritoneal, Endometrial and Uterine Cancers
1 other identifier
interventional
31
1 country
1
Brief Summary
The primary aim of this study is:
- To determine the overall clinical response rate of weekly Topotecan and Taxotere in women with recurrent ovarian, primary peritoneal, endometrial and uterine cancers. The secondary aims of this study are:
- To evaluate the safety and tolerability of the combination therapy with weekly Topotecan and Taxotere in patients with recurrent ovarian, primary peritoneal, endometrial or uterine cancers.
- To determine the progression free survival and overall survival in women treated with weekly Topotecan and Taxotere in patients with recurrent ovarian, primary peritoneal, endometrial and uterine cancers who have been previously treated with chemotherapy and/or radiation therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2004
1 active site
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
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 30, 2005
CompletedFirst Posted
Study publicly available on registry
October 4, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2007
CompletedApril 24, 2012
April 1, 2012
September 30, 2005
April 22, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine the overall clinical response rate of weekly Topotecan and Taxotere in women with recurrent ovarian, primary peritoneal, endometrial and uterine cancers
Secondary Outcomes (2)
To evaluate the safety and tolerability of weekly Topotecan and Taxotere in patients with recurrent ovarian, primary peritoneal, endometrial or uterine cancers
To determine the progression free survival and overall survival with weekly Topotecan and Taxotere in patients with recurrent ovarian, primary peritoneal, endometrial and uterine cancers who have been previously treated with chemotherapy
Interventions
Eligibility Criteria
You may qualify if:
- Histologically documented recurrent endometrial adenocarcinoma, papillary serous (UPSC), or mixed mullerian tumor (MMT) for which a cure or substantial palliation is unlikely using surgery and/or radiotherapy. Patients must have measurable disease or disease felt to be reproducibly measurable on CT scan, chest x-ray and/or tumor marker elevations .
- Recurrent ovarian or primary peritoneal cancers as defined as either:
- Measurable disease either by physical examination or by imaging or
- Non-measurable evidence of disease such as any or all of the following standard Rustin criteria:
- Peritoneal implants \<2 cm
- Abnormal densities on computerized tomography (CT) scan and/or loculated fluid collections
- Elevated CA-125 (\>100 U/mL on 2 measurements at least 1 week apart) and disease- related symptoms.
- Patients with the following histologic ovarian or uterine epithelial cell types are eligible:
- Serous adenocarcinoma
- Endometrioid adenocarcinoma
- Mucinous adenocarcinoma
- Undifferentiated carcinoma
- Clear cell adenocarcinoma
- Mixed epithelial carcinoma
- Transitional cell
- +13 more criteria
You may not qualify if:
- Patient has impairment of hepatic, renal or hematologic function as defined by the following baseline laboratory values:
- Serum creatinine clearance ≤ 50 ml/min
- Platelets \<100,000/mm3
- Absolute neutrophil count (ANC) \<1500/mm3
- Hemoglobin \<8.0 g/dl (the patient may be transfused prior to study entry)
- History of chronic or active hepatitis
- Patient has severe or uncontrolled medical disease (eg. uncontrolled diabetes, unstable angina, myocardial infarction within 6 months, congestive heart failure, etc.)
- Patients with dementia or altered mental status that would prohibit the giving and understanding of informed consent at time of study entry.
- Patients with a history of severe hypersensitivity to Taxotere®, Topotecan®, or other drugs formulated with polysorbate 80.
- Women who are pregnant or breast-feeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Montefiore Medical Centerlead
- Sanoficollaborator
- GlaxoSmithKlinecollaborator
Study Sites (1)
Montefiore Medical Center
The Bronx, New York, 10461, United States
Related Publications (1)
Gupta D, Owers RL, Kim M, Kuo DY, Huang GS, Shahabi S, Goldberg GL, Einstein MH. A phase II study of weekly topotecan and docetaxel in heavily treated patients with recurrent uterine and ovarian cancers. Gynecol Oncol. 2009 Jun;113(3):327-30. doi: 10.1016/j.ygyno.2009.02.018.
PMID: 19307014RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark H Einstein, M.D., M.S.
Montefiore Medical Center and Albert Einstein College of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Clinical Research for Women's Health
Study Record Dates
First Submitted
September 30, 2005
First Posted
October 4, 2005
Study Start
November 1, 2004
Study Completion
March 1, 2007
Last Updated
April 24, 2012
Record last verified: 2012-04