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

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ClinicalTrials.gov Identifier: NCT00107419

Recruitment Status : Completed

First Posted : April 6, 2005

Last Update Posted : January 18, 2012

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

Southwest Oncology Group

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.

Condition or disease	Intervention/treatment	Phase
Sarcoma	Drug: pemetrexed disodium	Phase 2

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.

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	75 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Phase II Trial of Pemetrexed for Advanced Chondrosarcomas
Study Start Date :	September 2005
Actual Primary Completion Date :	May 2007
Actual Study Completion Date :	August 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Pemetrexed Pemetrexed disodium

Genetic and Rare Diseases Information Center resources: Soft Tissue Sarcoma Chondrosarcoma

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

Response rate as measured by RECIST criteria [ Time Frame: every 9 weeks during treatment ]
x-rays or scans

Secondary Outcome Measures :

Toxicity as measured by CTC v 3.0 [ Time Frame: every 3 weeks during treatment ]
side-effect evaluation
Response rate compared with methylthioadenosine phosphorylase (MTAP) deletions as measured by fluorescence in-situ hybridization (FISH) retrospectively [ Time Frame: end of study ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00107419

Show 58 Study Locations

Sponsors and Collaborators

Southwest Oncology Group

National Cancer Institute (NCI)

Investigators


Study Chair:	Warren A. Chow, MD	City of Hope Comprehensive Cancer Center
Study Chair:	Ernest C. Borden, MD	The Cleveland Clinic
Study Chair:	Vivien H.C. Bramwell, MB, BS, PhD, FRCP	Tom Baker Cancer Centre - Calgary
Study Chair:	George D. Demetri, MD	Dana-Farber Cancer Institute
Study Chair:	Margaret von Mehren, MD	Fox Chase Cancer Center

More Information


Responsible Party:	Southwest Oncology Group
ClinicalTrials.gov Identifier:	NCT00107419 History of Changes
Other Study ID Numbers:	CDR0000415848 S0423 ( Other Identifier: SWOG ) U10CA032102 ( U.S. NIH Grant/Contract )
First Posted:	April 6, 2005 Key Record Dates
Last Update Posted:	January 18, 2012
Last Verified:	January 2012

Keywords provided by Southwest Oncology Group:


chondrosarcoma

Additional relevant MeSH terms:


Chondrosarcoma Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Sarcoma	Pemetrexed Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors

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