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

Sarcoma Clinical Trial

Official title:

Phase II Trial of Pemetrexed for Advanced Chondrosarcomas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00107419
• Other study ID #: CDR0000415848
• Secondary ID: S0423U10CA032102
• Status: Completed
• Phase: Phase 2
• First received: April 5, 2005
• Last updated: January 13, 2012
• Start date: September 2005
• Est. completion date: August 2009

Study information

• Verified date: January 2012
• Source: Southwest Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: August 2009
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chondrosarcoma
• Sarcoma

Intervention

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

Locations

Country	Name	City	State
United States	AnMed Health Cancer Center	Anderson	South Carolina
United States	Rush-Copley Cancer Care Center	Aurora	Illinois
United States	St. Joseph Cancer Center	Bellingham	Washington
United States	CCOP - Montana Cancer Consortium	Billings	Montana
United States	Deaconess Billings Clinic - Downtown	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	Cancer Research Center at Boston Medical Center	Boston	Massachusetts
United States	Bozeman Deaconess Hospital	Bozeman	Montana
United States	Olympic Hematology and Oncology	Bremerton	Washington
United States	St. James Community Hospital	Butte	Montana
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	Medical City Dallas Hospital	Dallas	Texas
United States	Wayne Memorial Hospital, Incorporated	Goldsboro	North Carolina
United States	Great Falls Clinic	Great Falls	Montana
United States	St. Peter's Hospital	Helena	Montana
United States	Community Oncology Group at Cleveland Clinic Cancer Center	Independence	Ohio
United States	Joliet Oncology-Hematology Associates, Limited - West	Joliet	Illinois
United States	Glacier Oncology, PLLC	Kalispell	Montana
United States	Kalispell Medical Oncology	Kalispell	Montana
United States	Kalispell Regional Medical Center	Kalispell	Montana
United States	Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center	Kansas City	Kansas
United States	St. Rita's Medical Center	Lima	Ohio
United States	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California
United States	Cardinal Bernardin Cancer Center at Loyola University Medical Center	Maywood	Illinois
United States	Saint Anthony Memorial Health Centers	Michigan City	Indiana
United States	Community Medical Center	Missoula	Montana
United States	Guardian Oncology and Center for Wellness	Missoula	Montana
United States	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center	Missoula	Montana
United States	Montana Cancer Specialists at Montana Cancer Center	Missoula	Montana
United States	Skagit Valley Hospital Cancer Care Center	Mt. Vernon	Washington
United States	Methodist Cancer Center at Methodist Hospital - Omaha	Omaha	Nebraska
United States	Fox Chase Cancer Center - Philadelphia	Philadelphia	Pennsylvania
United States	Oregon Health & Science University Cancer Institute	Portland	Oregon
United States	Rutherford Hospital	Rutherfordton	North Carolina
United States	Tammy Walker Cancer Center at Salina Regional Health Center	Salina	Kansas
United States	Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center	Savannah	Georgia
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington
United States	Group Health Central Hospital	Seattle	Washington
United States	Harborview Medical Center	Seattle	Washington
United States	Minor and James Medical, PLLC	Seattle	Washington
United States	Polyclinic First Hill	Seattle	Washington
United States	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus	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-Wooley	Washington
United States	Welch Cancer Center at Sheridan Memorial Hospital	Sheridan	Wyoming
United States	CCOP - Upstate Carolina	Spartanburg	South Carolina
United States	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center	Spartanburg	South Carolina
United States	Cancer Care Northwest - Spokane South	Spokane	Washington
United States	CCOP - Cancer Research for the Ozarks	Springfield	Missouri
United States	Hulston Cancer Center at Cox Medical Center South	Springfield	Missouri
United States	St. John's Regional Health Center	Springfield	Missouri
United States	Carle Cancer Center at Carle Foundation Hospital	Urbana	Illinois
United States	CCOP - Carle Cancer Center	Urbana	Illinois
United States	Wenatchee Valley Medical Center	Wenatchee	Washington
United States	Cleveland Clinic - Wooster	Wooster	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Southwest Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate as measured by RECIST criteria	x-rays or scans	every 9 weeks during treatment	No
Secondary	Toxicity as measured by CTC v 3.0	side-effect evaluation	every 3 weeks during treatment	Yes
Secondary	Response rate compared with methylthioadenosine phosphorylase (MTAP) deletions as measured by fluorescence in-situ hybridization (FISH) retrospectively		end of study	No