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Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00671788 |
RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well dasatinib works in treating patients with persistent or recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.
Condition | Intervention | Phase |
Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer |
Drug: dasatinib |
Phase II |
MedlinePlus related topics: | Cancer Ovarian Cancer |
ChemIDplus related topics: | Dasatinib |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Evaluation of Dasatinib (Sprycel®, NSC #732517) in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma |
Estimated Enrollment: | 50 |
Study Start Date: | June 2008 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive oral dasatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube cancer
Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest dimension to be recorded) as ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
Has ≥ 1 target lesion to assess response
Must have received 1 prior platinum-based chemotherapeutic regimen containing carboplatin, cisplatin, or other organoplatinum compound for management of primary disease
PATIENT CHARACTERISTICS:
Magnesium, calcium, phosphate, potassium, and sodium corrected to normal
No history of cardiac disease, including any of the following:
No history of significant bleeding disorder unrelated to cancer, including any of the following:
PRIOR CONCURRENT THERAPY:
At least 7 days since prior drugs known to prolong the QT interval, including any of the following:
At least 1 week since prior hormonal therapy directed at the malignant tumor
No prior noncytotoxic therapy for recurrent or persistent disease
More than 5 years since prior radiotherapy to any portion of the abdominal cavity or pelvis other than for the treatment of ovarian, fallopian tube, or primary peritoneal cancer
More than 5 years since prior chemotherapy for any abdominal or pelvic tumor other than for the treatment of ovarian, fallopian tube, or primary peritoneal cancer
Concurrent warfarin for prophylaxis or treatment of thrombosis allowed
United States, Connecticut | |||||
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center | Recruiting | ||||
Hartford, Connecticut, United States, 06105 | |||||
Contact: Allan R. Mayer, DO 860-714-7945 | |||||
United States, Florida | |||||
Sarasota Memorial Hospital | Recruiting | ||||
Sarasota, Florida, United States, 34239 | |||||
Contact: Clinical Trials Office - Sarasota Memorial Hospital 941-917-2225 | |||||
United States, Iowa | |||||
Holden Comprehensive Cancer Center at University of Iowa | Recruiting | ||||
Iowa City, Iowa, United States, 52242-1002 | |||||
Contact: Cancer Information Service 800-237-1225 | |||||
United States, Missouri | |||||
Hulston Cancer Center at Cox Medical Center South | Recruiting | ||||
Springfield, Missouri, United States, 65807 | |||||
Contact: Robert L. Carolla 417-269-5257 | |||||
St. John's Regional Health Center | Recruiting | ||||
Springfield, Missouri, United States, 65804 | |||||
Contact: Robert L. Carolla 417-820-2000 | |||||
United States, Nebraska | |||||
Methodist Estabrook Cancer Center | Recruiting | ||||
Omaha, Nebraska, United States, 68114 | |||||
Contact: Peter C. Morris, MD 402-354-5250 | |||||
United States, North Carolina | |||||
Blumenthal Cancer Center at Carolinas Medical Center | Recruiting | ||||
Charlotte, North Carolina, United States, 28232-2861 | |||||
Contact: Clinical Trials Office - Blumenthal Cancer Center at Carolinas 704-355-2884 | |||||
United States, Oklahoma | |||||
Oklahoma University Cancer Institute | Recruiting | ||||
Oklahoma City, Oklahoma, United States, 73104 | |||||
Contact: Robert S. Mannel, MD 405-271-8787 | |||||
United States, Pennsylvania | |||||
Rosenfeld Cancer Center at Abington Memorial Hospital | Recruiting | ||||
Abington, Pennsylvania, United States, 19001 | |||||
Contact: Clinical Trials Office - Rosenfeld Cancer Center at Abington M 215-481-2402 | |||||
York Cancer Center at Apple Hill Medical Center | Recruiting | ||||
York, Pennsylvania, United States, 17403 | |||||
Contact: Timothy B. McGuinness, DO 717-741-8100 |
Gynecologic Oncology Group |
National Cancer Institute (NCI) |
Study Chair: | Russell J. Schilder, MD | Fox Chase Cancer Center |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000594930, GOG-0170M |
First Received: | May 2, 2008 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00671788 |
Health Authority: | Unspecified |
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