Full Text View
Tabular View
No Study Results Posted
Related Studies
Study of Gemcitabine, Oxaliplatin, and Paclitaxel in Patients With Refractory Germ Cell Carcinoma
This study is currently recruiting participants.
Verified by USC/Norris Comprehensive Cancer Center, July 2009
First Received: September 9, 2005   Last Updated: July 24, 2009   History of Changes
Sponsors and Collaborators: USC/Norris Comprehensive Cancer Center
Sanofi-Aventis
Information provided by: USC/Norris Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00183820
  Purpose

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 Intervention Phase
Testicular Cancer
Germ Cell Neoplasm
Drug: paclitaxel, gemcitabine, and oxaliplatin
Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: A Phase II Study of Gemcitabine, Oxaliplatin, and Paclitaxel in Patients With Refractory Germ Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by USC/Norris Comprehensive Cancer Center:

Primary Outcome Measures:
  • Tumor Response [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression [ Time Frame: Every 9 wks ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: November 2004
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental 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

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00183820

Contacts
Contact: David Quinn, MD 323-865-0470 diquinn@usc.edu

Locations
United States, California
Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: David Quinn, MD     323-865-0470     diquinn@usc.edu    
Sponsors and Collaborators
USC/Norris Comprehensive Cancer Center
Sanofi-Aventis
Investigators
Principal Investigator: David Quinn, MD USC/Norris Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: University of Southern California ( Dr. David Quinn )
Study ID Numbers: 4T-03-1
Study First Received: September 9, 2005
Last Updated: July 24, 2009
ClinicalTrials.gov Identifier: NCT00183820     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by USC/Norris Comprehensive Cancer Center:
Testicular
Extra gonadal germ cell neoplasm

Study placed in the following topic categories:
Antimetabolites
Anti-Infective Agents
Genital Neoplasms, Male
Immunologic Factors
Gonadal Disorders
Urogenital Neoplasms
Oxaliplatin
Neoplasms, Germ Cell and Embryonal
Gemcitabine
Extragonadal Germ Cell Tumor
Endocrine Gland Neoplasms
Testicular Cancer
Testicular Diseases
Endocrine System Diseases
Testicular Neoplasms
Antimitotic Agents
Genital Diseases, Male
Antiviral Agents
Immunosuppressive Agents
Carcinoma
Radiation-Sensitizing Agents
Paclitaxel
Tubulin Modulators
Endocrinopathy
Antineoplastic Agents, Phytogenic

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Genital Neoplasms, Male
Molecular Mechanisms of Pharmacological Action
Gonadal Disorders
Antineoplastic Agents
Physiological Effects of Drugs
Urogenital Neoplasms
Oxaliplatin
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Therapeutic Uses
Gemcitabine
Endocrine Gland Neoplasms
Neoplasms by Histologic Type
Mitosis Modulators
Testicular Diseases
Endocrine System Diseases
Enzyme Inhibitors
Antimitotic Agents
Testicular Neoplasms
Genital Diseases, Male
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Radiation-Sensitizing Agents
Paclitaxel

ClinicalTrials.gov processed this record on September 10, 2009