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Phase II Trial of Pemetrexed for Advanced Chondrosarcomas

Phase 2
18 Years
Not Enrolling

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Trial Information

Phase II Trial of Pemetrexed for Advanced Chondrosarcomas



- 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.


- 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

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

Inclusion Criteria


- 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



- 18 and over

Performance status

- Zubrod 0-2

Life expectancy

- Not specified


- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3


- Bilirubin < 1.5 times upper limit of normal (ULN)

- SGOT or SGPT < 2.5 times ULN (5 times ULN if liver metastases are present)


- Creatinine clearance > 45 mL/min


- 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


Biologic therapy

- More than 28 days since prior biologic therapy for this malignancy


- More than 28 days since prior chemotherapy for this malignancy

Endocrine therapy

- Not specified


- 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


- At least 21 days since prior surgery and recovered


- More than 28 days since prior investigational drugs for this malignancy

- At least 60 days since prior embolization or radiofrequency ablation to the target

- 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:


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:


Principal Investigator

Warren A. Chow, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Beckman Research Institute


United States: Federal Government

Study ID:




Start Date:

September 2005

Completion Date:

August 2009

Related Keywords:

  • Sarcoma
  • chondrosarcoma
  • Chondrosarcoma
  • Sarcoma



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