SWOG clinical trial number
S0423

Phase II Trial of Pemetrexed for Advanced Chondrosarcomas

Closed
Phase
Accrual
19%
Abbreviated Title
Chondrosarcoma
Activated
09/01/2005
Closed
01/15/2007
Participants
NCORP, Members, Surgeons, Pathologists, CTSU Institutions in the United States, Intergroup Coalition Against Sarcomas Members in the United States

Research committees

Sarcoma

Treatment

Pemetrexed

Eligibility Criteria Expand/Collapse

Cytologic or histologic diagnosis of G2 or G3 chondrosarcoma that is either recurrent and unresectable, or metastatic. No known CNS mets. Pretreatment specimens must be submitted. Measurable disease. Measurable disease asssessed within 28 days prior to reg; non-measurable disease assessed within 42 days prior to reg. Zubrod 0-2. May have received up to 2 prior regimens for this malignancy. No chemo, biologic or any investigational drug for this malignancy within 28 days prior to reg. Must not currently be receiving RT. At least 60 days must have elapsed since any prior RT, embolization or RFA to the target lesion, and the lesion must have demonstrated progression following completion of therapy. At least 21 days must have elapsed since any prior surgery, and must have recovered from all effects. Must be able to swallow oral meds. Must be at least 18 yo. Must not be HIV-positive and receiving anti-retroviral therapy. Must not be pregnant or nursing. If of reproductive potential, must have agreed to use effective contraceptive method. Within 28 days prior to reg: ANC greater than or equal to 1,500/mcl; Platelets greater than or equal to 100,000/mcl; bilirubin less than 1.5 x IULN; SGOT or SGPT less than 2.5 x IULN (if liver mets, SGOT or SGPT less than 5 x IULN); measured or estimated creatinine clearance > 45 ml/min. No other prior malignancy except the following: adequately terated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the pateint has been disease free for five years.