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S0423 Pemetrexed Disodium in Treating Patients With Recurrent and Unresectable or Metastatic Chondrosarcoma

Primary Purpose

Sarcoma

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

pemetrexed disodium

About this trial

This is an interventional treatment trial for Sarcoma focused on measuring chondrosarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: 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

Sites / Locations

USC/Norris Comprehensive Cancer Center and Hospital
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Rush-Copley Cancer Care Center
Joliet Oncology-Hematology Associates, Limited - West
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Carle Cancer Center at Carle Foundation Hospital
CCOP - Carle Cancer Center
Saint Anthony Memorial Health Centers
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Tammy Walker Cancer Center at Salina Regional Health Center
Cancer Research Center at Boston Medical Center
CCOP - Cancer Research for the Ozarks
St. John's Regional Health Center
Hulston Cancer Center at Cox Medical Center South
CCOP - Montana Cancer Consortium
Hematology-Oncology Centers of the Northern Rockies - Billings
Northern Rockies Radiation Oncology Center
St. Vincent Healthcare
Deaconess Billings Clinic - Downtown
Bozeman Deaconess Hospital
St. James Community Hospital
Great Falls Clinic
St. Peter's Hospital
Glacier Oncology, PLLC
Kalispell Medical Oncology
Kalispell Regional Medical Center
Community Medical Center
Guardian Oncology and Center for Wellness
Montana Cancer Specialists at Montana Cancer Center
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Methodist Cancer Center at Methodist Hospital - Omaha
Wayne Memorial Hospital, Incorporated
Rutherford Hospital
Cleveland Clinic Taussig Cancer Center
Community Oncology Group at Cleveland Clinic Cancer Center
St. Rita's Medical Center
Cleveland Clinic - Wooster
Oregon Health & Science University Cancer Institute
Fox Chase Cancer Center - Philadelphia
AnMed Health Cancer Center
CCOP - Upstate Carolina
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Medical City Dallas Hospital
St. Joseph Cancer Center
Olympic Hematology and Oncology
Skagit Valley Hospital Cancer Care Center
Fred Hutchinson Cancer Research Center
Harborview Medical Center
Minor and James Medical, PLLC
Group Health Central Hospital
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Polyclinic First Hill
University Cancer Center at University of Washington Medical Center
North Puget Oncology at United General Hospital
Cancer Care Northwest - Spokane South
Wenatchee Valley Medical Center
Welch Cancer Center at Sheridan Memorial Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

pemetrexed

Arm Description

pemetrexed

Outcomes

Primary Outcome Measures

Response rate as measured by RECIST criteria

x-rays or scans

Secondary Outcome Measures

Toxicity as measured by CTC v 3.0

side-effect evaluation

Response rate compared with methylthioadenosine phosphorylase (MTAP) deletions as measured by fluorescence in-situ hybridization (FISH) retrospectively

Full Information

NCT ID

NCT00107419

First Posted

April 5, 2005

Last Updated

January 13, 2012

Sponsor

SWOG Cancer Research Network

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00107419

Brief Title

S0423 Pemetrexed Disodium in Treating Patients With Recurrent and Unresectable or Metastatic Chondrosarcoma

Official Title

Phase II Trial of Pemetrexed for Advanced Chondrosarcomas

Study Type

Interventional

2. Study Status

Record Verification Date

January 2012

Overall Recruitment Status

Completed

Study Start Date

September 2005 (undefined)

Primary Completion Date

May 2007 (Actual)

Study Completion Date

August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

SWOG Cancer Research Network

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well pemetrexed disodium works in treating patients with recurrent and unresectable or metastatic chondrosarcoma.

Detailed Description

OBJECTIVES: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sarcoma

Keywords

chondrosarcoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

75 (Actual)

8. Arms, Groups, and Interventions

Arm Title

pemetrexed

Arm Type

Experimental

Arm Description

pemetrexed

Intervention Type

Drug

Intervention Name(s)

pemetrexed disodium

Intervention Description

pemetrexed, 500 mg/m2, IV, every 21 days until two cycles after complete response or until progression

Primary Outcome Measure Information:

Title

Response rate as measured by RECIST criteria

Description

x-rays or scans

Time Frame

every 9 weeks during treatment

Secondary Outcome Measure Information:

Title

Toxicity as measured by CTC v 3.0

Description

side-effect evaluation

Time Frame

every 3 weeks during treatment

Title

Response rate compared with methylthioadenosine phosphorylase (MTAP) deletions as measured by fluorescence in-situ hybridization (FISH) retrospectively

Time Frame

end of study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials: