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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 Center Seattle, Washington  98109
Cardinal Bernardin Cancer Center at Loyola University Medical Center Maywood, Illinois  60153-5500
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
Medical City Dallas Hospital Dallas, Texas  75230
CCOP - Carle Cancer Center Urbana, Illinois  61801
Rush-Copley Cancer Care Center Aurora, Illinois  60507
Joliet Oncology-Hematology Associates, Limited - West Joliet, Illinois  60435
Carle Cancer Center at Carle Foundation Hospital Urbana, Illinois  61801
Saint Anthony Memorial Health Centers Michigan City, Indiana  46360
St. Rita's Medical Center Lima, Ohio  45801
CCOP - Cancer Research for the Ozarks Springfield, Missouri  65807
CCOP - Montana Cancer Consortium Billings, Montana  59101
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
USC/Norris Comprehensive Cancer Center and Hospital Los Angeles, California  90033-0804
Great Falls Clinic Great Falls, Montana  59405
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center Kansas City, Kansas  66160-7353
Cancer Research Center at Boston Medical Center Boston, Massachusetts  02118
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Seattle, Washington  98104
Hulston Cancer Center at Cox Medical Center South Springfield, Missouri  65807
St. John's Regional Health Center Springfield, Missouri  65804
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center Savannah, Georgia  31403-3089
Northern Rockies Radiation Oncology Center Billings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - Billings Billings, Montana  59101
St. Vincent Healthcare Billings, Montana  59101
Deaconess Billings Clinic - Downtown Billings, Montana  59101
Bozeman Deaconess Hospital Bozeman, Montana  59715
St. James Community Hospital Butte, Montana  59701
St. Peter's Hospital Helena, Montana  59601
Kalispell Medical Oncology Kalispell, Montana  59901
Kalispell Regional Medical Center Kalispell, Montana  59901
Glacier Oncology, PLLC Kalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula, Montana  59802
Montana Cancer Specialists at Montana Cancer Center Missoula, Montana  59802
Community Medical Center Missoula, Montana  59801
Wayne Memorial Hospital, Incorporated Goldsboro, North Carolina  27534
Olympic Hematology and Oncology Bremerton, Washington  98310
Skagit Valley Hospital Cancer Care Center Mt. Vernon, Washington  98273
University Cancer Center at University of Washington Medical Center Seattle, Washington  98195
Harborview Medical Center Seattle, Washington  98104
Group Health Central Hospital Seattle, Washington  98104
North Puget Oncology at United General Hospital Sedro-Wooley, Washington  98284
Cancer Care Northwest - Spokane South Spokane, Washington  99202
Fox Chase Cancer Center - Philadelphia Philadelphia, Pennsylvania  19111-2497
Community Oncology Group at Cleveland Clinic Cancer Center Independence, Ohio  44131
Cleveland Clinic - Wooster Wooster, Ohio  44691
Minor and James Medical, PLLC Seattle, Washington  98104
Polyclinic First Hill Seattle, Washington  98122
Welch Cancer Center at Sheridan Memorial Hospital Sheridan, Wyoming  82801
Tammy Walker Cancer Center at Salina Regional Health Center Salina, Kansas  67401
St. Joseph Cancer Center Bellingham, Washington  98225
Wenatchee Valley Medical Center Wenatchee, Washington  98801-2028
Methodist Cancer Center at Methodist Hospital - Omaha Omaha, Nebraska  68114
Oregon Health & Science University Cancer Institute Portland, Oregon  97239-3098
Rutherford Hospital Rutherfordton, North Carolina  28139
AnMed Health Cancer Center Anderson, South Carolina  29621
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg, South Carolina  29303
Great Falls, Montana  59405
Guardian Oncology and Center for Wellness Missoula, Montana  59804