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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00107419
First received: April 5, 2005
Last updated: January 13, 2012
Last verified: January 2012
History of Changes
  Purpose

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 Intervention Phase
Sarcoma
 Drug: pemetrexed disodium
 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Pemetrexed for Advanced Chondrosarcomas

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Response rate as measured by RECIST criteria [ Time Frame: every 9 weeks during treatment ] [ Designated as safety issue: No ]
    x-rays or scans


Secondary Outcome Measures:
  • Toxicity as measured by CTC v 3.0 [ Time Frame: every 3 weeks during treatment ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
Enrollment: 75
Study Start Date: September 2005
Study Completion Date: August 2009
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: pemetrexed
pemetrexed
 Drug: pemetrexed disodium
pemetrexed, 500 mg/m2, IV, every 21 days until two cycles after complete response or until progression

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.

  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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  U10CA032102 
Study First Received: April 5, 2005
Last Updated: January 13, 2012
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on September 23, 2016