S0423 Pemetrexed Disodium in Treating Patients With Recurrent and Unresectable or Metastatic Chondrosarcoma
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| ClinicalTrials.gov Identifier: NCT00107419 |
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Recruitment Status :
Completed
First Posted : April 6, 2005
Last Update Posted : January 18, 2012
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Sarcoma | Drug: pemetrexed disodium | Phase 2 |
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 (Clinical Trial) |
| Actual Enrollment : | 75 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Phase II Trial of Pemetrexed for Advanced Chondrosarcomas |
| Study Start Date : | September 2005 |
| Actual Primary Completion Date : | May 2007 |
| Actual Study Completion Date : | August 2009 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: pemetrexed
pemetrexed
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Drug: pemetrexed disodium
pemetrexed, 500 mg/m2, IV, every 21 days until two cycles after complete response or until progression |
- Response rate as measured by RECIST criteria [ Time Frame: every 9 weeks during treatment ]x-rays or scans
- Toxicity as measured by CTC v 3.0 [ Time Frame: every 3 weeks during treatment ]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 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00107419
Show 58 study locations
| 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 |
| Responsible Party: | Southwest Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00107419 |
| Other Study ID Numbers: |
CDR0000415848 S0423 ( Other Identifier: SWOG ) U10CA032102 ( U.S. NIH Grant/Contract ) |
| First Posted: | April 6, 2005 Key Record Dates |
| Last Update Posted: | January 18, 2012 |
| Last Verified: | January 2012 |
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chondrosarcoma |
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Chondrosarcoma Sarcoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Neoplasms, Connective Tissue |
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