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

January 13, 2012 updated by: Southwest Oncology Group

Phase II Trial of Pemetrexed for Advanced Chondrosarcomas

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90089-9181
        • USC/Norris Comprehensive Cancer Center and Hospital
    • Georgia
      • Savannah, Georgia, United States, 31403-3089
        • Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
    • Illinois
      • Aurora, Illinois, United States, 60507
        • Rush-Copley Cancer Care Center
      • Joliet, Illinois, United States, 60435
        • Joliet Oncology-Hematology Associates, Limited - West
      • Maywood, Illinois, United States, 60153
        • Cardinal Bernardin Cancer Center at Loyola University Medical Center
      • Urbana, Illinois, United States, 61801
        • Carle Cancer Center at Carle Foundation Hospital
      • Urbana, Illinois, United States, 61801
        • CCOP - Carle Cancer Center
    • Indiana
      • Michigan City, Indiana, United States, 46360
        • Saint Anthony Memorial Health Centers
    • Kansas
      • Kansas City, Kansas, United States, 66160-7357
        • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
      • Salina, Kansas, United States, 67401
        • Tammy Walker Cancer Center at Salina Regional Health Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Cancer Research Center at Boston Medical Center
    • Missouri
      • Springfield, Missouri, United States, 65802
        • CCOP - Cancer Research for the Ozarks
      • Springfield, Missouri, United States, 65804
        • St. John's Regional Health Center
      • Springfield, Missouri, United States, 65807
        • Hulston Cancer Center at Cox Medical Center South
    • Montana
      • Billings, Montana, United States, 59101
        • CCOP - Montana Cancer Consortium
      • Billings, Montana, United States, 59101
        • Hematology-Oncology Centers of the Northern Rockies - Billings
      • Billings, Montana, United States, 59101
        • Northern Rockies Radiation Oncology Center
      • Billings, Montana, United States, 59101
        • St. Vincent Healthcare
      • Billings, Montana, United States, 59107-7000
        • Deaconess Billings Clinic - Downtown
      • Bozeman, Montana, United States, 59715
        • Bozeman Deaconess Hospital
      • Butte, Montana, United States, 59701
        • St. James Community Hospital
      • Great Falls, Montana, United States, 59405
        • Great Falls Clinic
      • Great Falls, Montana, United States, 59405
      • Helena, Montana, United States, 59601
        • St. Peter's Hospital
      • Kalispell, Montana, United States, 59901
        • Kalispell Regional Medical Center
      • Kalispell, Montana, United States, 59901
        • Glacier Oncology, PLLC
      • Kalispell, Montana, United States, 59901
        • Kalispell Medical Oncology
      • Missoula, Montana, United States, 59801
        • Community Medical Center
      • Missoula, Montana, United States, 59804
        • Guardian Oncology and Center for Wellness
      • Missoula, Montana, United States, 59807-7877
        • Montana Cancer Specialists at Montana Cancer Center
      • Missoula, Montana, United States, 59807
        • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Methodist Cancer Center at Methodist Hospital - Omaha
    • North Carolina
      • Goldsboro, North Carolina, United States, 27534
        • Wayne Memorial Hospital, Incorporated
      • Rutherfordton, North Carolina, United States, 28139
        • Rutherford Hospital
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Taussig Cancer Center
      • Independence, Ohio, United States, 44131
        • Community Oncology Group at Cleveland Clinic Cancer Center
      • Lima, Ohio, United States, 45801
        • St. Rita's Medical Center
      • Wooster, Ohio, United States, 44691
        • Cleveland Clinic - Wooster
    • Oregon
      • Portland, Oregon, United States, 97239-3098
        • Oregon Health & Science University Cancer Institute
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111-2497
        • Fox Chase Cancer Center - Philadelphia
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • AnMed Health Cancer Center
      • Spartanburg, South Carolina, United States, 29303
        • CCOP - Upstate Carolina
      • Spartanburg, South Carolina, United States, 29303
        • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
    • Texas
      • Dallas, Texas, United States, 75230
        • Medical City Dallas Hospital
    • Washington
      • Bellingham, Washington, United States, 98225
        • St. Joseph Cancer Center
      • Bremerton, Washington, United States, 98310
        • Olympic Hematology and Oncology
      • Mt. Vernon, Washington, United States, 98273
        • Skagit Valley Hospital Cancer Care Center
      • Seattle, Washington, United States, 98104
        • Harborview Medical Center
      • Seattle, Washington, United States, 98104
        • Fred Hutchinson Cancer Research Center
      • Seattle, Washington, United States, 98104
        • Minor and James Medical, PLLC
      • Seattle, Washington, United States, 98112
        • Group Health Central Hospital
      • Seattle, Washington, United States, 98122-4307
        • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
      • Seattle, Washington, United States, 98122
        • Polyclinic First Hill
      • Seattle, Washington, United States, 98195-6043
        • University Cancer Center at University of Washington Medical Center
      • Sedro-Wooley, Washington, United States, 98284
        • North Puget Oncology at United General Hospital
      • Spokane, Washington, United States, 99202
        • Cancer Care Northwest - Spokane South
      • Wenatchee, Washington, United States, 98801-2028
        • Wenatchee Valley Medical Center
    • Wyoming
      • Sheridan, Wyoming, United States, 82801
        • Welch Cancer Center at Sheridan Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southwest Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Margaret von Mehren, MD, Fox Chase Cancer Center
  • 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

April 5, 2005

First Submitted That Met QC Criteria

April 5, 2005

First Posted (Estimate)

April 6, 2005

Study Record Updates

Last Update Posted (Estimate)

January 18, 2012

Last Update Submitted That Met QC Criteria

January 13, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000415848
  • U10CA032102 (U.S. NIH Grant/Contract)
  • S0423 (Other Identifier: SWOG)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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