Status:
COMPLETED
Study of Gemcitabine, Oxaliplatin, and Paclitaxel in Patients With Refractory Germ Cell Carcinoma
Lead Sponsor:
University of Southern California
Collaborating Sponsors:
Sanofi
Conditions:
Testicular Cancer
Germ Cell Neoplasm
Eligibility:
MALE
16+ years
Phase:
PHASE2
Brief Summary
This is a study for patients with advanced testicular cancer. This research study involves treatment with oxaliplatin, paclitaxel, and gemcitabine, which is an investigational chemotherapy combination...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00183820
Start Date
November 1 2004
End Date
August 1 2016
Last Update
July 7 2017
Active Locations (1)
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1
Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033