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

Phase 2
16 Years
Open (Enrolling)
Testicular Cancer, Germ Cell Neoplasm

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Trial Information

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

Inclusion Criteria:

1. Prior histologic or serologic confirmation of testicular or extragonadal germ cell
neoplasm not amenable to surgical cure

2. 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

3. 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.

4. X-rays, scans, or PE for non-measurable dz must have been completed within 14 days of

5. 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

6. Zubrod PS less than or equal to 2

7. Greater than or equal to 16 years of age

8. AGC greater than or equal to 1.5; platelets greater than or equal to 100,000

9. Total bilirubin < 2.5 x uln; SGOT and alk phos < 5 x uln (obtained within 14 days
prior to registration)

10. LDH (obtained within 7 days prior to registration)

11. 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

12. Serum K+ and Mg++ within inst range of normal (obtained within 14 days prior to

13. Men of reproductive potential must agree to use effective contraceptive method

14. Signed informed consent (including HIPAA authorization)

Exclusion Criteria:

1. Prior tx with cytotoxic or experimental agents within 14 days prior to registration

2. Evidence of concurrent infection (T > 96.8F but < 101.5F; WBC < 11.0 unless these
values can be ascribed to another tumor-related phenomena)

3. 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor Response

Outcome Time Frame:

Every 6 weeks

Safety Issue:


Principal Investigator

David Quinn, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

USC/Norris Comprehensive Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

November 2004

Completion Date:

June 2014

Related Keywords:

  • Testicular Cancer
  • Germ Cell Neoplasm
  • Testicular
  • Extra gonadal germ cell neoplasm
  • Neoplasms
  • Carcinoma
  • Testicular Neoplasms
  • Neoplasms, Germ Cell and Embryonal



Norris Comprehensive Cancer Center Los Angeles, California  90033