PTK787 - ZK 222584 in Treating Patients With Unresectable Malignant Mesothelioma

http://www.clinicaltrials.gov/ct/show/NCT00053885?amp;order=4

This study is currently recruiting patients.

Sponsored by : Cancer and Leukemia Group B

National Cancer Institute (NCI)

Purpose

RATIONALE: PTK787/ZK 222584 may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.

PURPOSE: Phase II trial to study the effectiveness of PTK787/ZK 222584 in treating patients with unresectablemalignant mesothelioma.

Study Type: Interventional

Study Design: Treatment

Official Title: Phase II Study of PTK787/ZK 222584 in Patients With Unresectable Malignant Mesothelioma

Further Study Details:

OBJECTIVES:

  • Determine the efficacy of PTK787/ZK 222584, in terms of 3-month progression-free survival, in patients with malignant mesothelioma.
  • Determine the response rate in patients treated with this drug.
  • Determine the toxicity of this drug in these patients.
  • Determine the overall and failure-free survival of patients treated with this drug.
  • Correlate pretreatment circulating serum levels of vascular endothelial growth factor (VEGF), platelet-derived growth factor, and VEGF mRNA isoforms with response in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive oral PTK787/ZK 222584 daily. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2 months for 1 year, every 4 months for 1 year, and then every 6 months for 1 year.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 9-13 months.

Eligibility

Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both

Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed malignant mesothelioma of 1 of the following types:
  • Epithelial
  • Sarcomatoid
  • Mixed
  • Not amenable to radiotherapy or curative surgery
  • Any site of origin including, but not limited to, the following:
  • Pleura
  • Peritoneum
  • Pericardium
  • Tunica vaginalis
  • At least one unidimensionally measurable lesion outside of prior irradiation port
  • At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
  • The following are not considered measurable:
  • Bone lesions
  • Leptomeningeal disease
  • Ascites
  • Pleural/pericardial effusion
  • Lymphangitis cutis/pulmonis
  • Abdominal masses that are not confirmed and followed by imaging techniques
  • Cystic lesions
  • No known brain metastases

PATIENT CHARACTERISTICS:

Age

  • Over 18

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST no greater than 2.5 times ULN

Renal

  • Creatinine no greater than 1.5 times ULN
  • Negative for proteinuria by dipstick OR
  • Urinary protein no greater than 500 mg and creatinine clearance at least 50 mL/min

Cardiovascular

  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective double-barrier contraception
  • No currently active second malignancy except non-melanoma skin cancers (unless therapy is completed and risk of relapse is less than 30%)
  • No other concurrent uncontrolled illness
  • No ongoing active infections
  • No psychiatric illness or social situation that would preclude study compliance

PRIOR CONCURRENT THERAPY: Biologic therapy

  • No prior signal transduction inhibitor therapy
  • No prior angiogenesis inhibitor therapy

Chemotherapy

  • No prior cytotoxic chemotherapy for this malignancy
  • No concurrent chemotherapeutic agents
  • Prior intrapleural cytotoxic or sclerosing therapy (including bleomycin) allowed

Endocrine therapy

  • No concurrent hormonal therapy except steroids for adrenal failure or hormones for non-disease-related conditions (e.g., insulin for diabetes)

Radiotherapy

  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy
  • No concurrent palliative radiotherapy

Surgery

  • See Disease Characteristics
  • At least 2 weeks since prior major surgery

Other

  • At least 30 days since prior investigational agents
  • At least 7 days since prior grapefruit or grapefruit juice
  • At least 7 days since prior CYP3A4 inducers
  • No prior PTK787/ZK 222584
  • No prior tyrosine kinase inhibitor therapy
  • No other concurrent investigational agents
  • No concurrent isoenzyme inducers or inhibitors of p450
  • No concurrent warfarin or similar oral anticoagulants
  • Heparin allowed
  • No concurrent grapefruit or grapefruit juice
  • No concurrent combination antiretroviral therapy for HIV-positive patients

Location and Contact Information

Alabama

Northeast Alabama Regional Medical Center, Anniston, Alabama, 36207, United States; Recruiting Thomas W. Twele, MD 256-236-2549

Veterans Affairs Medical Center - Birmingham, Birmingham, Alabama, 35233-1996, United States; Recruiting Francisco Robert, MD, FACP 205-933-8101

California

Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center, Los Angeles, California, 90048, United States; Recruiting Alan T. Lefor, MD 310-423-5874 Alan.Lefor@cshs.org

Naval Medical Center - San Diego, San Diego, California, 92134-3202, United States; Recruiting Charles S. Kuzma, MD 619-532-7303

Rebecca and John Moores UCSD Cancer Center, La Jolla, California, 92093-0658, United States; Recruiting Stephen L. Seagren, MD 858-657-7020

UCSF Comprehensive Cancer Center, San Francisco, California, 94115, United States; Recruiting Alan Paul Venook, MD 800-888-8664

Veterans Affairs Medical Center - San Diego, San Diego, California, 92161, United States; Recruiting Saeeda Kirmani, MD 619-552-8585 ext. 3356 skirmani@ucsd.edu

Veterans Affairs Medical Center - San Francisco, San Francisco, California, 94121, United States; Recruiting Patricia A. Cornett, MD 415-221-4810 ext. 3423 patricia.cornett@med.va.gov

Delaware

CCOP - Christiana Care Health Services, Newark, Delaware, 19713, United States; Recruiting Stephen Scott Grubbs, MD 302-623-4100

District of Columbia

Lombardi Cancer Center at Georgetown University Medical Center, Washington, District of Columbia, 20007, United States; Recruiting Edward P. Gelmann, MD 202-444-7303 gelmanne@georgetown.edu

Veterans Affairs Medical Center - Washington, DC, Washington, District of Columbia, 20422, United States; Recruiting Steven H. Krasnow, MD 202-745-8178 krasnow.steven@washington.va.gov

Walter Reed Army Medical Center, Washington, District of Columbia, 20307-5000, United States; Recruiting Thomas Joseph Reid, MD, PhD, FACP 202-782-6751

Florida

Broward General Medical Center, Fort Lauderdale, Florida, 33316, United States; Recruiting Luis Ramon Barreras, MD, FACP 954-771-0692

CCOP - Mount Sinai Medical Center, Miami Beach, Florida, 33140, United States; Recruiting Rogerio C. Lilenbaum, MD 305-674-2625

Florida Hospital Cancer Institute, Orlando, Florida, 32804, United States; Recruiting Jane Crofton, RN, BSN, OCN 407-303-2090

Memorial Regional Cancer Center at Memorial Regional Hospital, Hollywood, Florida, 33021, United States; Recruiting Atif M. Hussein, MD 954-986-6363

Illinois

CCOP - Illinois Oncology Research Association, Peoria, Illinois, 61602, United States; Recruiting John W. Kugler, MD 309-636-3605

Louis A. Weiss Memorial Hospital, Chicago, Illinois, 60640, United States; Recruiting Keith L. Shulman, MD 773-564-5022 KShulman@weisshospital.org

MBCCOP - University of Illinois at Chicago, Chicago, Illinois, 60612, United States; Recruiting Lawrence E. Feldman, MD 312-335-3614

Saint Anthony Medical Center, Rockford, Illinois, 61108, United States; Recruiting Richard E. Nora, MD 815-227-2273 richard.e.nora@osfhealthcare.org

University of Chicago Cancer Research Center, Chicago, Illinois, 60637-1470, United States; Recruiting Karen Wendling 773-834-7424

Veterans Affairs Medical Center - Chicago (Westside Hospital), Chicago, Illinois, 60612, United States; Recruiting Thomas E. Lad, MD 312-996-2046

West Suburban Center for Cancer Care, River Forest, Illinois, 60305, United States; Recruiting John L. Showel, MD 708-763-2700

Indiana

CCOP - Northern Indiana CR Consortium, South Bend, Indiana, 46601, United States; Recruiting Rafat H. Ansari, MD, FACP 574-284-7977

Fort Wayne Medical Oncology and Hematology, Incorporated, Fort Wayne, Indiana, 46885-5099, United States; Recruiting Sreenivasa Rao Nattam, MD 219-484-8830 ledgar@fwmoh.com

Iowa

Holden Comprehensive Cancer Center at University of Iowa, Iowa City, Iowa, 52242-1009, United States; Recruiting Gerald H. Clamon, MD 319-356-8110

Kentucky

Baptist Hospital East - Louisville, Louisville, Kentucky, 40207, United States; Recruiting Daniel C. Scullin, MD 502-897-1166

Maryland

Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore, Maryland, 21201, United States; Recruiting Martin J. Edelman, MD 410-328-2703 medelman@umm.edu

Massachusetts

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston, Massachusetts, 02115, United States; Recruiting George P. Canellos, MD 617-632-3470 george_canellos@dfci.harvard.edu

University of Massachusetts Memorial Medical Center - University Campus, Worcester, Massachusetts, 01655, United States; Recruiting Pankaj Bhargava 508-856-6884 bhargavp@ummhc.org

Michigan

Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph, Saint Joseph, Michigan, 49085, United States; Recruiting Eric P. Lester, MD 269-982-4963

Minnesota

University of Minnesota Cancer Center, Minneapolis, Minnesota, 55455, United States; Recruiting Bruce A. Peterson, MD 612-624-5631

Veterans Affairs Medical Center - Minneapolis, Minneapolis, Minnesota, 55417, United States; Recruiting Vicki A. Morrison, MD 612-725-2000 ext. 4135 morri002@tc.umn.edu

Missouri

CCOP - Kansas City, Kansas City, Missouri, 64131, United States; Recruiting Jorge C. Paradelo, MD 816-823-0555 kccop@kccop.org

Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia, Missouri, 65203, United States; Recruiting Michael C. Perry, MD 573-882-4979 perrym@health.missouri.edu

Missouri Baptist Cancer Center, Saint Louis, Missouri, 63131, United States; Recruiting Alan Philip Lyss, MD 314-996-5514 alyss@bjc.org

Siteman Cancer Center, Saint Louis, Missouri, 63110, United States; Recruiting Nancy Bartlett, MD 314-362-4843

Veterans Affairs Medical Center - Columbia (Truman Memorial), Columbia, Missouri, 65201, United States; Recruiting William P. Patterson, MD 573-882-6163

Nebraska

UNMC Eppley Cancer Center at the University of Nebraska Medical Center, Omaha, Nebraska, 68198-7680, United States; Recruiting Margaret Anne Kessinger, MD 402-559-7511 makessin@unmc.edu

Nevada

CCOP - Southern Nevada Cancer Research Foundation, Las Vegas, Nevada, 89106, United States; Recruiting John Allan Ellerton, MD, CM 702-384-0013 k.vavwagenen@sncrf.com

Veterans Affairs Medical Center - Las Vegas, Las Vegas, Nevada, 89106, United States; Recruiting Chitha R. Hulugalle, MD 702-696-3000

New Hampshire

New Hampshire Oncology-Hematology, PA - Hooksett, Hooksett, New Hampshire, 03106, United States; Recruiting Douglas Jay Weckstein, MD 603-622-6484 d.weckstein@nhoh.com

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, 03756-0002, United States; Recruiting Marc Stuart Ernstoff, MD 603-650-5534 Marc.S.Ernstoff@Hitchcock.org

New Jersey

Cooper University Hospital, Camden, New Jersey, 08103, United States; Recruiting Edison Catalano, MD 856-342-2506

New York

CCOP - North Shore University Hospital, Manhasset, New York, 11030, United States; Recruiting Vincent P. Vinciguerra, MD 516-562-8954

CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C., East Syracuse, New York, 13057, United States; Recruiting Jeffrey J. Kirshner, MD 315-472-7504

Elmhurst Hospital Center, Elmhurst, New York, 11373, United States; Recruiting Vladimir Benisovich, MD 718-334-3723 beniso@aol.com

Memorial Sloan-Kettering Cancer Center, New York, New York, 10021, United States; Recruiting Clifford A. Hudis, MD 212-639-6483

Mount Sinai Medical Center, NY, New York, New York, 10029, United States; Recruiting Lewis R. Silverman, MD 212-241-5520 lewis.silverman@mssm.edu

New York Weill Cornell Cancer Center at Cornell University, New York, New York, 10021, United States; Recruiting Scott Wadler, MD 212-746-2844

North Shore University Hospital, Manhasset, New York, 11030, United States; Recruiting Daniel R. Budman, MD 516-562-8958

Queens Cancer Center of Queens Hospital, Jamaica, New York, 11432, United States; Recruiting Hans W. Grunwald, MD 718-883-4118 hans.grunwald@mssm.edu

Roswell Park Cancer Institute, Buffalo, New York, 14263-0001, United States; Recruiting Ellis G. Levine, MD 716-845-8547

University Hospital at State University of New York - Upstate Medical University, Syracuse, New York, 13210, United States; Recruiting Stephen L. Graziano, MD 315-464-8200 grazians@upstate.edu

Veterans Affairs Medical Center - Buffalo, Buffalo, New York, 14215, United States; Recruiting Lynn Marie Steinbrenner, MD 716-862-3191 lynn.steinbrenner@med.va.gov

Veterans Affairs Medical Center - Syracuse, Syracuse, New York, 13210, United States; Recruiting Stephen L. Graziano, MD 315-476-7461

North Carolina

Cape Fear Valley Health System, Fayetteville, North Carolina, 28302-2000, United States; Recruiting Kamal M. Bakri, MD 910-609-6910

CCOP - Southeast Cancer Control Consortium, Winston Salem, North Carolina, 27104-4241, United States; Recruiting James N. Atkins, MD 336-777-3036

Comprehensive Cancer Center at Wake Forest University, Winston Salem, North Carolina, 27157-1082, United States; Recruiting David Duane Hurd, MD 336-716-2088 dhurd@wfubmc.edu

Duke Comprehensive Cancer Center, Durham, North Carolina, 27710, United States; Recruiting Jeffrey Crawford, MD 919-684-5195 crawf006@mc.duke.edu

FirstHealth Moore Regional Hospital, Pinehurst, North Carolina, 28374, United States; Recruiting Ellen M. Willard, MD 910-295-9205

Lenoir Memorial Hospital Cancer Center, Kinston, North Carolina, 28503-1678, United States; Recruiting Peter R. Watson, MD 919-559-2200 Ext. 201

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill, North Carolina, 27599-7295, United States; Recruiting Thomas C. Shea, MD 919-966-7746

New Hanover Regional Medical Center, Wilmington, North Carolina, 28402-9025, United States; Recruiting Cyrus A. Kotwall, MD 910-763-4630

NorthEast Oncology Associates, Concord, North Carolina, 28025, United States; Recruiting James Grier Wall, MD 704-783-1370 jwall@northeastmedical.org

Veterans Affairs Medical Center - Asheville, Asheville, North Carolina, 28805, United States; Recruiting John C. Lucke, MD 828-299-2540

Veterans Affairs Medical Center - Durham, Durham, North Carolina, 27705, United States; Recruiting Michael J. Kelley, MD 919-286-0411

Ohio

Arthur G. James Cancer Hospital - Ohio State University, Columbus, Ohio, 43210-1240, United States; Recruiting Clara D. Bloomfield, MD 614-293-7518 bloomfield-1@medctr.osu.edu

Oklahoma

Oklahoma University Medical Center at University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, 73104, United States; Recruiting Howard Ozer, MD, PhD 405-271-4022

Pennsylvania

Western Pennsylvania Hospital, Pittsburgh, Pennsylvania, 15224, United States; Recruiting Richard K. Shadduck, MD 412-578-4355 rshadduck@msn.com

Rhode Island

Lifespan: The Miriam Hospital, Providence, Rhode Island, 02906, United States; Recruiting William M. Sikov, MD 401-793-7151 wsikov@lifespan.org

Tennessee

University of Tennessee Cancer Institute, Memphis, Tennessee, 38104, United States; Recruiting Harvey B. Niell, MD 901-448-5150 hniell@utmem.edu

Veterans Affairs Medical Center - Memphis, Memphis, Tennessee, 38104, United States; Recruiting Harvey B. Niell, MD 901-523-8990 ext. 5533

Texas

Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas, Texas, 75390-8852, United States; Recruiting Debasish Tripathy, MD 214-648-7705

Veterans Affairs Medical Center - Dallas, Dallas, Texas, 75219, United States; Recruiting Jonathan Dowell, MD 214-857-0737

Vermont

Vermont Cancer Center at University of Vermont, Burlington, Vermont, 05401-3498, United States; Recruiting Hyman Bernard Muss, MD 802-847-3827

Virginia

Martha Jefferson Hospital, Charlottesville, Virginia, 22902, United States; Recruiting Stefan M. Gorsch, MD 434-982-8410

MBCCOP - Massey Cancer Center, Richmond, Virginia, 23298-0037, United States; Recruiting John D. Roberts, MD 804-828-0450

Oncology and Hematology Associates of Southwest Virginia, Inc., Roanoke, Virginia, 24014, United States; Recruiting Paul D. Richards, MD 540-982-0237 paul.richards@usoncology.com

Virginia Oncology Associates - Norfolk, Norfolk, Virginia, 23502, United States; Recruiting Paul R. Conkling, MD 757-466-8683

West Virginia

St. Mary's Medical Center, Huntington, West Virginia, 25701, United States; Recruiting Gerrit A. Kimmey, MD 304-528-4645

Study chairs or principal investigators

Thierry Jahan, MD, Study Chair, University of California, San Francisco

*** POSTED JULY 19, 2004 ***