COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH:
Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00183820
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : July 7, 2017
Information provided by (Responsible Party):
University of Southern California

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. This study is for patients who have not responded to standard cisplatin-containing chemotherapy or the cancer has returned after such treatment.

This research is being done to assess the effectiveness of the proposed combination of medications for this type of cancer.

Condition or disease Intervention/treatment Phase
Testicular Cancer Germ Cell Neoplasm Drug: paclitaxel, gemcitabine, and oxaliplatin Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Gemcitabine, Oxaliplatin, and Paclitaxel in Patients With Refractory Germ Cell Carcinoma
Study Start Date : November 2004
Actual Primary Completion Date : December 2015
Actual Study Completion Date : August 2016

Arm Intervention/treatment
Experimental: 1 Drug: paclitaxel, gemcitabine, and oxaliplatin
  1. Paclitaxel 170 mg/m2 IV d 1 14 days
  2. Gemcitabine 800 mg/m2 IV d 1 14 days
  3. Oxaliplatin 100 mg/m2 IV d 1 14 days

Primary Outcome Measures :
  1. Tumor Response [ Time Frame: Every 6 weeks ]

Secondary Outcome Measures :
  1. Progression [ Time Frame: Every 9 wks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00183820

Layout table for location information
United States, California
Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
Layout table for investigator information
Principal Investigator: David Quinn, MD University of Southern California
Layout table for additonal information
Responsible Party: University of Southern California Identifier: NCT00183820    
Other Study ID Numbers: 4T-03-1
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: July 7, 2017
Last Verified: July 2017
Keywords provided by University of Southern California:
Extra gonadal germ cell neoplasm
Additional relevant MeSH terms:
Layout table for MeSH terms
Testicular Neoplasms
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Neoplasms by Site
Genital Neoplasms, Male
Urogenital Neoplasms
Endocrine System Diseases
Testicular Diseases
Gonadal Disorders
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs