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| Sponsor: | Mayo Clinic |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT01012817 |
Purpose
RATIONALE: ABT-888 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as topotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving ABT-888 together with topotecan hydrochloride may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of giving ABT-888 together with topotecan hydrochloride and to see how well it works in treating patients with advanced solid tumors or relapsed or refractory ovarian epithelial cancer or primary peritoneal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer Peritoneal Cavity Cancer Unspecified Adult Solid Tumor, Protocol Specific |
Drug: ABT-888 Drug: topotecan hydrochloride Other: laboratory biomarker analysis Other: pharmacological study |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase I/II Trial of ABT-888, an Inhibitor of Poly(ADP-ribose) Polymerase (PARP), and Topotecan (TPT) in Patients With Solid Tumors (Phase I) and Relapsed or Refractory Ovarian Cancer or Primary Peritoneal Cancer (Phase II) After Prior Platinum Containing First-Line Chemotherapy |
| Estimated Enrollment: | 104 |
| Study Start Date: | October 2009 |
| Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: Patients receive oral ABT-888 once daily on days 1-3, 8-10, and 15-17*. Patients also receive topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
NOTE: *Patients do not receive ABT-888 on days 1-3 during course 2.
Patients undergo blood and urine sample collection periodically for pharmacokinetic, pharmacogenetic, and other correlative laboratory studies. Patients enrolled in phase II also undergo tumor tissue collection at baseline for biomarker laboratory studies.
After completion of study treatment, patients are followed up every 3-6 months for up to 5 years.
PROJECTED ACCRUAL: A total of 104 patients (56 for phase I and 48 for phase II) will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
Histologically confirmed malignant solid tumor (phase I)
Histologically confirmed ovarian epithelial or primary peritoneal cancer (phase II)
No known CNS metastases
PATIENT CHARACTERISTICS:
No concurrent uncontrolled illness including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United States, Arizona | |
| Mayo Clinic Scottsdale | Recruiting |
| Scottsdale, Arizona, United States, 85259-5499 | |
| Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 | |
| United States, Florida | |
| Mayo Clinic - Jacksonville | Recruiting |
| Jacksonville, Florida, United States, 32224 | |
| Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 | |
| United States, Minnesota | |
| Mayo Clinic Cancer Center | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 | |
| Principal Investigator: | Michael Menefee, MD | Mayo Clinic |
More Information
| Responsible Party: | Mayo Clinic Cancer Center ( Michael Menefee ) |
| Study ID Numbers: | CDR0000657976, MAYO-MC0861, 8329 |
| Study First Received: | November 11, 2009 |
| Last Updated: | November 11, 2009 |
| ClinicalTrials.gov Identifier: | NCT01012817 History of Changes |
| Health Authority: | Unspecified |
|
unspecified adult solid tumor, protocol specific recurrent ovarian epithelial cancer peritoneal cavity cancer |
|
Digestive System Neoplasms Endocrine Gland Neoplasms Genital Neoplasms, Female Ovarian Neoplasms Urogenital Neoplasms Neoplasms by Site Ovarian Diseases Neoplasms Peritoneal Neoplasms Abdominal Neoplasms Molecular Mechanisms of Pharmacological Action |
Antineoplastic Agents Gonadal Disorders Endocrine System Diseases Enzyme Inhibitors Pharmacologic Actions Adnexal Diseases Genital Diseases, Female Digestive System Diseases Therapeutic Uses Peritoneal Diseases Topotecan |