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Phase II Trial of Pemetrexed for Advanced Chondrosarcomas


Phase 2
18 Years
N/A
Not Enrolling
Both
Sarcoma

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Trial Information

Phase II Trial of Pemetrexed for Advanced Chondrosarcomas


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Response rate as measured by RECIST criteria

Outcome Description:

x-rays or scans

Outcome Time Frame:

every 9 weeks during treatment

Safety Issue:

No

Principal Investigator

Warren A. Chow, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Beckman Research Institute

Authority:

United States: Federal Government

Study ID:

CDR0000415848

NCT ID:

NCT00107419

Start Date:

September 2005

Completion Date:

August 2009

Related Keywords:

  • Sarcoma
  • chondrosarcoma
  • Chondrosarcoma
  • Sarcoma

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywood, Illinois  60153-5500
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
Medical City Dallas HospitalDallas, Texas  75230
CCOP - Carle Cancer CenterUrbana, Illinois  61801
Rush-Copley Cancer Care CenterAurora, Illinois  60507
Joliet Oncology-Hematology Associates, Limited - WestJoliet, Illinois  60435
Carle Cancer Center at Carle Foundation HospitalUrbana, Illinois  61801
Saint Anthony Memorial Health CentersMichigan City, Indiana  46360
St. Rita's Medical CenterLima, Ohio  45801
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Great Falls ClinicGreat Falls, Montana  59405
Kansas Masonic Cancer Research Institute at the University of Kansas Medical CenterKansas City, Kansas  66160-7353
Cancer Research Center at Boston Medical CenterBoston, Massachusetts  02118
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical CenterSavannah, Georgia  31403-3089
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
St. Vincent HealthcareBillings, Montana  59101
Deaconess Billings Clinic - DowntownBillings, Montana  59101
Bozeman Deaconess HospitalBozeman, Montana  59715
St. James Community HospitalButte, Montana  59701
St. Peter's HospitalHelena, Montana  59601
Kalispell Medical OncologyKalispell, Montana  59901
Kalispell Regional Medical CenterKalispell, Montana  59901
Glacier Oncology, PLLCKalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
Community Medical CenterMissoula, Montana  59801
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Olympic Hematology and OncologyBremerton, Washington  98310
Skagit Valley Hospital Cancer Care CenterMt. Vernon, Washington  98273
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
Harborview Medical CenterSeattle, Washington  98104
Group Health Central HospitalSeattle, Washington  98104
North Puget Oncology at United General HospitalSedro-Wooley, Washington  98284
Cancer Care Northwest - Spokane SouthSpokane, Washington  99202
Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497
Community Oncology Group at Cleveland Clinic Cancer CenterIndependence, Ohio  44131
Cleveland Clinic - WoosterWooster, Ohio  44691
Minor and James Medical, PLLCSeattle, Washington  98104
Polyclinic First HillSeattle, Washington  98122
Welch Cancer Center at Sheridan Memorial HospitalSheridan, Wyoming  82801
Tammy Walker Cancer Center at Salina Regional Health CenterSalina, Kansas  67401
St. Joseph Cancer CenterBellingham, Washington  98225
Wenatchee Valley Medical CenterWenatchee, Washington  98801-2028
Methodist Cancer Center at Methodist Hospital - OmahaOmaha, Nebraska  68114
Oregon Health & Science University Cancer InstitutePortland, Oregon  97239-3098
Rutherford HospitalRutherfordton, North Carolina  28139
AnMed Health Cancer CenterAnderson, South Carolina  29621
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Great Falls, Montana  59405
Guardian Oncology and Center for WellnessMissoula, Montana  59804