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A Phase II Study of PTK787/ZK222584 (NSC#719335) in Patients With Unresectable Malignant Mesothelioma


Phase 2
18 Years
N/A
Not Enrolling
Both
Malignant Mesothelioma

Thank you

Trial Information

A Phase II Study of PTK787/ZK222584 (NSC#719335) in Patients With Unresectable Malignant Mesothelioma


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Thierry Jahan, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, San Francisco

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000269537

NCT ID:

NCT00053885

Start Date:

July 2003

Completion Date:

June 2006

Related Keywords:

  • Malignant Mesothelioma
  • advanced malignant mesothelioma
  • epithelial mesothelioma
  • recurrent malignant mesothelioma
  • sarcomatous mesothelioma
  • Mesothelioma

Name

Location

Roswell Park Cancer Institute Buffalo, New York  14263
Memorial Sloan-Kettering Cancer Center New York, New York  10021
Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
University of Chicago Cancer Research Center Chicago, Illinois  60637
University of Minnesota Cancer Center Minneapolis, Minnesota  55455
Duke Comprehensive Cancer Center Durham, North Carolina  27710
CCOP - Kansas City Kansas City, Missouri  64131
CCOP - Southern Nevada Cancer Research Foundation Las Vegas, Nevada  89106
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
CCOP - Mount Sinai Medical Center Miami Beach, Florida  33140
CCOP - North Shore University Hospital Manhasset, New York  11030
CCOP - Southeast Cancer Control Consortium Winston-Salem, North Carolina  27104-4241
MBCCOP - Massey Cancer Center Richmond, Virginia  23298-0037
CCOP - Illinois Oncology Research Association Peoria, Illinois  61602
Comprehensive Cancer Center at Wake Forest University Winston-Salem, North Carolina  27157-1082
Veterans Affairs Medical Center - Birmingham Birmingham, Alabama  35233
Western Pennsylvania Hospital Pittsburgh, Pennsylvania  15224
Martha Jefferson Hospital Charlottesville, Virginia  22901
MBCCOP - University of Illinois at Chicago Chicago, Illinois  60612
CCOP - Northern Indiana CR Consortium South Bend, Indiana  46601
Holden Comprehensive Cancer Center at University of Iowa Iowa City, Iowa  52242-1002
UMASS Memorial Cancer Center - University Campus Worcester, Massachusetts  01605-2982
Ellis Fischel Cancer Center at University of Missouri - Columbia Columbia, Missouri  65203
Siteman Cancer Center at Barnes-Jewish Hospital Saint Louis, Missouri  63110
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire  03756-0002
Cancer Institute of New Jersey at the Cooper University Hospital Camden, New Jersey  08103-1489
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill, North Carolina  27599-7570
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Columbus, Ohio  43210-1240
North Shore University Hospital Manhasset, New York  11030
Veterans Affairs Medical Center - Chicago (Westside Hospital) Chicago, Illinois  60612
Naval Medical Center - San Diego San Diego, California  92134-3202
Veterans Affairs Medical Center - San Francisco San Francisco, California  94121
Baptist Hospital East - Louisville Louisville, Kentucky  40207
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. Syracuse, New York  13217
Veterans Affairs Medical Center - Memphis Memphis, Tennessee  38104
Veterans Affairs Medical Center - Minneapolis Minneapolis, Minnesota  55417
Veterans Affairs Medical Center - Columbia (Truman Memorial) Columbia, Missouri  65201
Veterans Affairs Medical Center - Buffalo Buffalo, New York  14215
Veterans Affairs Medical Center - Syracuse Syracuse, New York  13210
Veterans Affairs Medical Center - Durham Durham, North Carolina  27705
Rebecca and John Moores UCSD Cancer Center La Jolla, California  92093-0658
Broward General Medical Center Fort Lauderdale, Florida  33316
Florida Hospital Cancer Institute Orlando, Florida  32804
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute Boston, Massachusetts  02115
Northeast Alabama Regional Medical Center Anniston, Alabama  36207
Veterans Affairs Medical Center - San Diego San Diego, California  92161
UCSF Comprehensive Cancer Center San Francisco, California  94115
Veterans Affairs Medical Center - Washington, DC Washington, District of Columbia  20422
Louis A. Weiss Memorial Hospital Chicago, Illinois  60640
West Suburban Center for Cancer Care River Forest, Illinois  60305
Fort Wayne Medical Oncology and Hematology, Incorporated Fort Wayne, Indiana  46885-5099
Veterans Affairs Medical Center - Las Vegas Las Vegas, Nevada  89106
Elmhurst Hospital Center Elmhurst, New York  11373
Queens Cancer Center of Queens Hospital Jamaica, New York  11432
Veterans Affairs Medical Center - Asheville Asheville, North Carolina  28805
Cape Fear Valley Health System Fayetteville, North Carolina  28302-2000
Lifespan: The Miriam Hospital Providence, Rhode Island  02906
Veterans Affairs Medical Center - Dallas Dallas, Texas  75216
Virginia Oncology Associates - Norfolk Norfolk, Virginia  23502
St. Mary's Medical Center Huntington, West Virginia  25701
Oklahoma University Medical Center Oklahoma City, Oklahoma  73104
Mount Sinai Medical Center New York, New York  10029
SUNY Upstate Medical University Hospital Syracuse, New York  13210
Vermont Cancer Center at University of Vermont Burlington, Vermont  05405-0075
Lombardi Cancer Center at Georgetown University Medical Center Washington, District of Columbia  20007
Greenebaum Cancer Center at University of Maryland Medical Center Baltimore, Maryland  21201
UNMC Eppley Cancer Center at the University of Nebraska Medical Center Omaha, Nebraska  68198-7680
New Hampshire Oncology-Hematology, PA - Hooksett Hooksett, New Hampshire  03106
NorthEast Oncology Associates - Concord Concord, North Carolina  28025
University of Tennessee Cancer Institute at Methodist Central Hospital Memphis, Tennessee  38104
Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke Roanoke, Virginia  24014
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph Saint Joseph, Michigan  49085
New York Weill Cornell Cancer Center at Cornell University New York, New York  10021
Lenoir Memorial Cancer Center Kinston, North Carolina  28503-1678
Comprehensive Cancer Center at Moore Regional Hospital Pinehurst, North Carolina  28374
Zimmer Cancer Center at New Hanover Regional Medical Center Wilmington, North Carolina  28402-9025
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center Los Angeles, California  90048
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas Dallas, Texas  75390-9063
Memorial Regional Cancer Center at Memorial Regional Hospital Hollywood, Florida  33021
Missouri Baptist Cancer Center St. Louis, Missouri  63131