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| Sponsor: | University of Chicago |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT01064622 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. GDC-0449 may slow the growth of tumor cells. It is not yet known whether giving gemcitabine hydrochloride together with GDC-0449 is more effective than gemcitabine hydrochloride alone in treating patients with pancreatic cancer.
PURPOSE: This randomized phase II trial is studying gemcitabine hydrochloride and GDC-0449 to see how well they work compared with gemcitabine hydrochloride alone in treating patients with recurrent or metastatic pancreatic cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer |
Drug: Hedgehog antagonist GDC-0449 Drug: gemcitabine hydrochloride Other: placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multi-Center, Double Blind, Placebo-Controlled, Randomized Phase II of Gemcitabine Plus GDC-0449 (NSC 747691), a Hh Pathway Inhibitor, in Patients With Metastatic Pancreatic Cancer (10052747) |
| Estimated Enrollment: | 118 |
| Study Start Date: | September 2009 |
| Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm I (part II)
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and oral placebo once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, patients are unblinded and may crossover to arm II.
|
Drug: gemcitabine hydrochloride
Given IV
Other: placebo
Given orally
|
|
Experimental: Arm II (part II)
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and oral hedgehog antagonist GDC-0449 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Drug: Hedgehog antagonist GDC-0449
Given orally
Drug: gemcitabine hydrochloride
Given IV
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed pancreatic adenocarcinoma meeting 1 of the following criteria:
Recurrent disease
PATIENT CHARACTERISTICS:
No "currently active" second malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix
No concurrent uncontrolled illness including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United States, California | |
| Tower Cancer Research Foundation | Recruiting |
| Beverly Hills, California, United States, 90211 | |
| Contact: Solomon I. Hamburg, MD, PhD 310-888-8680 | |
| City of Hope Comprehensive Cancer Center | Recruiting |
| Duarte, California, United States, 91010-3000 | |
| Contact: Clinical Trials Office - City of Hope Comprehensive Cancer Cen 800-826-4673 becomingapatient@coh.org | |
| USC/Norris Comprehensive Cancer Center and Hospital | Recruiting |
| Los Angeles, California, United States, 90089-9181 | |
| Contact: Clinical Trials Office - USC/Norris Comprehensive Cancer Cente 323-865-0451 | |
| City of Hope Medical Group | Recruiting |
| Pasadena, California, United States, 91105 | |
| Contact: Mark V. McNamara, MD 626-396-2900 mmcnamara@ccsmg.com | |
| University of California Davis Cancer Center | Recruiting |
| Sacramento, California, United States, 95817 | |
| Contact: Clinical Trials Office - University of California Davis Cancer 916-734-3089 | |
| United States, Illinois | |
| University of Chicago Cancer Research Center | Recruiting |
| Chicago, Illinois, United States, 60637-1470 | |
| Contact: Clinical Trials Office - University of Chicago Cancer Research 773-834-7424 | |
| Decatur Memorial Hospital Cancer Care Institute | Recruiting |
| Decatur, Illinois, United States, 62526 | |
| Contact: Clinical Trials Office - Decatur Memorial Hospital Cancer Care 217-876-4750 | |
| Evanston Hospital | Recruiting |
| Evanston, Illinois, United States, 60201-1781 | |
| Contact: Clinical Trials Office - Evanston Hospital 847-570-1381 | |
| Ingalls Cancer Care Center at Ingalls Memorial Hospital | Recruiting |
| Harvey, Illinois, United States, 60426 | |
| Contact: Clinical Trials Office - Ingalls Cancer Care Center at Ingalls 708-915-4673 | |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | Recruiting |
| Maywood, Illinois, United States, 60153 | |
| Contact: Clinical Trials Office - Cardinal Bernardin Cancer Center 708-226-4357 | |
| Oncology Hematology Associates of Central Illinois, PC - Peoria | Recruiting |
| Peoria, Illinois, United States, 61615-7828 | |
| Contact: Sachdev P. Thomas, MD 309-243-1000 sthomas@ohaci.com | |
| Central Illinois Hematology Oncology Center | Recruiting |
| Springfield, Illinois, United States, 62701 | |
| Contact: Edem S. Agamah, MD, MS 217-525-2500 ihdn@aol.com | |
| United States, Indiana | |
| Fort Wayne Medical Oncology and Hematology | Recruiting |
| Fort Wayne, Indiana, United States, 46885-5099 | |
| Contact: Sreenivasa R. Nattam, MD 260-484-8830 ledgar@fwmoh.com | |
| United States, Maryland | |
| Greenebaum Cancer Center at University of Maryland Medical Center | Recruiting |
| Baltimore, Maryland, United States, 21201 | |
| Contact: Clinical Trials Office - Greenebaum Cancer Center at Universit 800-888-8823 | |
| Cancer Institute at St. Joseph Medical Center | Recruiting |
| Towson, Maryland, United States, 21204 | |
| Contact: Richard Schrader, MD 410-427-5585 | |
| United States, Michigan | |
| University of Michigan Comprehensive Cancer Center | Recruiting |
| Ann Arbor, Michigan, United States, 48109-0942 | |
| Contact: Clinical Trials Office - University of Michigan Comprehensive 800-865-1125 | |
| United States, Missouri | |
| David C. Pratt Cancer Center at St. John's Mercy | Recruiting |
| Saint Louis, Missouri, United States, 63141 | |
| Contact: Clinical Trials Office - David C. Pratt Cancer Center at St. J 314-251-6770 | |
| United States, New York | |
| Albert Einstein Cancer Center at Albert Einstein College of Medicine | Recruiting |
| Bronx, New York, United States, 10461 | |
| Contact: Clinical Trials Office - Albert Einstein Cancer Center at Albe 718-904-2730 aecc@aecom.yu.edu | |
| Montefiore Medical Center | Recruiting |
| Bronx, New York, United States, 10467 | |
| Contact: Andreas Kaubisch, MD 718-920-4826 | |
| New York Weill Cornell Cancer Center at Cornell University | Recruiting |
| New York, New York, United States, 10021 | |
| Contact: Clinical Trials Office - New York Weill Cornell Cancer Center 212-746-1848 | |
| NYU Cancer Institute at New York University Medical Center | Recruiting |
| New York, New York, United States, 10016 | |
| Contact: Howard S. Hochster, MD 212-731-5100 howard.hochster@med.nyu.edu | |
| United States, Pennsylvania | |
| Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center | Recruiting |
| Hershey, Pennsylvania, United States, 17033-0850 | |
| Contact: Clinical Trials Office - Penn State Hershey Cancer Institute a 717-531-3779 CTO@hmc.psu.edu | |
| UPMC Cancer Centers | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| Contact: Clinical Trials Office - UPMC Cancer Centers 412-647-8073 | |
| United States, Wisconsin | |
| Medical College of Wisconsin Cancer Center | Recruiting |
| Milwaukee, Wisconsin, United States, 53226 | |
| Contact: Clinical Trials Office - Medical College of Wisconsin Cancer C 414-805-4380 | |
| Principal Investigator: | Hedy L. Kindler, MD | University of Chicago |
More Information
| Responsible Party: | Dale Rush, University of Chicago Cancer Research Center |
| ClinicalTrials.gov Identifier: | NCT01064622 History of Changes |
| Other Study ID Numbers: | CDR0000655378, UCCRC-8418, 8418 |
| Study First Received: | February 5, 2010 |
| Last Updated: | February 22, 2011 |
| Health Authority: | Unspecified |
|
stage IV pancreatic cancer adenocarcinoma of the pancreas recurrent pancreatic cancer |
|
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Gemcitabine Antimetabolites, Antineoplastic Antimetabolites |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents |