Study of Gemcitabine, Oxaliplatin, and Paclitaxel in Patients With Refractory Germ Cell Carcinoma

Inclusion criteria

• Prior histologic or serologic confirmation of testicular or extragonadal germ cell neoplasm not amenable to surgical cure
• Must have refractory germ cell neoplasm defined as one or more of the following:

• patients who progress during or within 4 weeks of cisplatin-containing tx, OR - patients who have failed initial salvage chemotx regimens, including high-dose tx (chemotx with stem cell support), POMB-ACE tx, VeIP, or VIP
• Must have one or more of the following (check all that apply):

• unidimensionally measurable doze assessed within 14 days prior to registration,
• elevated β-HCG > 20 mIU assessed within 24-48 hours prior to registration, OR
• AFP > 2 x uln assessed within 5-7 days prior to registration

Note: Soft tissue dz, which has been radiated in the 2 months prior to registration, is not assessable as measurable dz.

• X-rays, scans, or PE for non-measurable dz must have been completed within 14 days of registration
• May have received prior surgery or RT. At least 3 weeks must have elapsed since completion of previous tx and must have recovered from any adverse effects
• Zubrod PS less than or equal to 2
• Greater than or equal to 16 years of age
• AGC greater than or equal to 1.5; platelets greater than or equal to 100,000
• Total bilirubin < 2.5 x uln; SGOT and alk phos < 5 x uln (obtained within 14 days prior to registration)
• LDH (obtained within 7 days prior to registration)
• Creatinine < 2.5 x uln or calc or meas CrCl greater than or equal to 40 ml/min (obtained within 14 days prior to registration; patient must not be on renal dialysis)
• Serum K+ and Mg++ within inst range of normal (obtained within 14 days prior to registration)
• Men of reproductive potential must agree to use effective contraceptive method
• Signed informed consent (including HIPAA authorization)

Exclusion criteria

• Prior tx with cytotoxic or experimental agents within 14 days prior to registration
• Evidence of concurrent infection (T > 96.8F but < 101.5F; WBC < 11.0 unless these values can be ascribed to another tumor-related phenomena)
• Other prior malignancy, except adequately treated basal cell or squamous cell skin cancer, adequately treated stage I or II cancer from which patient is currently in chemoradiation (CR), or any other cancer from which patient has been disease-free for 5 years