S0423 Pemetrexed Disodium in Treating Patients With Recurrent and Unresectable or Metastatic Chondrosarcoma
NCT ID: NCT00107419
Last Updated: 2012-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
75 participants
INTERVENTIONAL
2005-09-30
2009-08-31
Brief Summary
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PURPOSE: This phase II trial is studying how well pemetrexed disodium works in treating patients with recurrent and unresectable or metastatic chondrosarcoma.
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Detailed Description
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Primary
* Determine the response rate (confirmed and unconfirmed complete response and partial response) in patients with recurrent and unresectable or metastatic chondrosarcoma treated with pemetrexed disodium.
Secondary
* Determine the toxicity of this drug in these patients.
* Correlate, preliminarily, response rates with deletions of methylthioadenosine phosphorylase (MTAP), as analyzed by fluorescence in-situ hybridization (FISH), in patients treated with this drug.
OUTLINE: This is a multicenter study. Patients are stratified according to prior chemotherapy (yes vs no).
Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days\* in the absence of disease progression or unacceptable toxicity. Beginning 7 days before the first dose of pemetrexed disodium and continuing until 21 days after the completion of pemetrexed disodium, patients receive cyanocobalamin (vitamin B\_12) intramuscularly once every 63 days and oral folic acid once daily.
NOTE: \*The duration of course 1 is 28 days; the duration of all subsequent courses is 21 days.
Patients achieving a complete response (CR) receive 2 additional courses beyond CR. Patients achieving a confirmed partial response (PR) that is resectable, proceed to surgical resection and then receive 2 additional courses of therapy after recovering from surgery. Patients achieving a confirmed PR that is not resectable continue treatment in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
PROJECTED ACCRUAL: A total of 40-75 patients (20-40 in the previously treated stratum and 20-35 in the previously untreated stratum) will be accrued for this study within 20-37.5 months.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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pemetrexed
pemetrexed
pemetrexed disodium
pemetrexed, 500 mg/m2, IV, every 21 days until two cycles after complete response or until progression
Interventions
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pemetrexed disodium
pemetrexed, 500 mg/m2, IV, every 21 days until two cycles after complete response or until progression
Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed chondrosarcoma
* Histologic grade G2 or G3
* Recurrent and unresectable OR metastatic disease
* Measurable disease by x-ray, scan, ultrasound, or physical examination
* No known CNS metastases
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Zubrod 0-2
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
Hepatic
* Bilirubin \< 1.5 times upper limit of normal (ULN)
* SGOT or SGPT \< 2.5 times ULN (5 times ULN if liver metastases are present)
Renal
* Creatinine clearance \> 45 mL/min
Other
* Not pregnant or nursing
* Fertile patients must use effective contraception
* Able to swallow oral medication
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission
PRIOR CONCURRENT THERAPY:
Biologic therapy
* More than 28 days since prior biologic therapy for this malignancy
Chemotherapy
* More than 28 days since prior chemotherapy for this malignancy
Endocrine therapy
* Not specified
Radiotherapy
* At least 60 days since prior radiotherapy to the target lesion\*
* No concurrent radiotherapy NOTE: \*Target lesion must have demonstrated disease progression after completion of therapy
Surgery
* At least 21 days since prior surgery and recovered
Other
* More than 28 days since prior investigational drugs for this malignancy
* At least 60 days since prior embolization or radiofrequency ablation to the target lesion\*
* No more than 2 prior treatment regimens for this malignancy
* No concurrent antiretroviral therapy for HIV-positive patients NOTE: \*Target lesion must have demonstrated disease progression after completion of therapy
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
SWOG Cancer Research Network
NETWORK
Responsible Party
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Principal Investigators
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Warren A. Chow, MD
Role: STUDY_CHAIR
City of Hope Comprehensive Cancer Center
Ernest C. Borden, MD
Role: STUDY_CHAIR
The Cleveland Clinic
Vivien H.C. Bramwell, MB, BS, PhD, FRCP
Role: STUDY_CHAIR
Tom Baker Cancer Centre - Calgary
George D. Demetri, MD
Role: STUDY_CHAIR
Dana-Farber Cancer Institute
Margaret von Mehren, MD
Role: STUDY_CHAIR
Fox Chase Cancer Center
Locations
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USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, United States
Rush-Copley Cancer Care Center
Aurora, Illinois, United States
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, United States
CCOP - Carle Cancer Center
Urbana, Illinois, United States
Saint Anthony Memorial Health Centers
Michigan City, Indiana, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States
Tammy Walker Cancer Center at Salina Regional Health Center
Salina, Kansas, United States
Cancer Research Center at Boston Medical Center
Boston, Massachusetts, United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States
St. John's Regional Health Center
Springfield, Missouri, United States
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States
CCOP - Montana Cancer Consortium
Billings, Montana, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, United States
Northern Rockies Radiation Oncology Center
Billings, Montana, United States
St. Vincent Healthcare
Billings, Montana, United States
Deaconess Billings Clinic - Downtown
Billings, Montana, United States
Bozeman Deaconess Hospital
Bozeman, Montana, United States
St. James Community Hospital
Butte, Montana, United States
Great Falls Clinic
Great Falls, Montana, United States
Great Falls, Montana, United States
St. Peter's Hospital
Helena, Montana, United States
Glacier Oncology, PLLC
Kalispell, Montana, United States
Kalispell Medical Oncology
Kalispell, Montana, United States
Kalispell Regional Medical Center
Kalispell, Montana, United States
Community Medical Center
Missoula, Montana, United States
Guardian Oncology and Center for Wellness
Missoula, Montana, United States
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, United States
Methodist Cancer Center at Methodist Hospital - Omaha
Omaha, Nebraska, United States
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States
Rutherford Hospital
Rutherfordton, North Carolina, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Community Oncology Group at Cleveland Clinic Cancer Center
Independence, Ohio, United States
St. Rita's Medical Center
Lima, Ohio, United States
Cleveland Clinic - Wooster
Wooster, Ohio, United States
Oregon Health & Science University Cancer Institute
Portland, Oregon, United States
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States
AnMed Health Cancer Center
Anderson, South Carolina, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States
Medical City Dallas Hospital
Dallas, Texas, United States
St. Joseph Cancer Center
Bellingham, Washington, United States
Olympic Hematology and Oncology
Bremerton, Washington, United States
Skagit Valley Hospital Cancer Care Center
Mount Vernon, Washington, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Harborview Medical Center
Seattle, Washington, United States
Minor and James Medical, PLLC
Seattle, Washington, United States
Group Health Central Hospital
Seattle, Washington, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, United States
Polyclinic First Hill
Seattle, Washington, United States
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States
North Puget Oncology at United General Hospital
Sedro-Woolley, Washington, United States
Cancer Care Northwest - Spokane South
Spokane, Washington, United States
Wenatchee Valley Medical Center
Wenatchee, Washington, United States
Welch Cancer Center at Sheridan Memorial Hospital
Sheridan, Wyoming, United States
Countries
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Other Identifiers
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S0423
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000415848
Identifier Type: -
Identifier Source: org_study_id
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