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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
University of Southern California
ClinicalTrials.gov Identifier:
NCT00183820
First received: September 9, 2005
Last updated: May 20, 2014
Last verified: May 2014
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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 University of Southern California:

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 ]

Enrollment: 30
Study Start Date: November 2004
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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
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, see Learn About Clinical Studies.

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

Locations
United States, California
Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
Sanofi
Investigators
Principal Investigator: David Quinn, MD University of Southern California
  More Information

No publications provided

Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT00183820     History of Changes
Other Study ID Numbers: 4T-03-1
Study First Received: September 9, 2005
Last Updated: May 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Southern California:
Testicular
Extra gonadal germ cell neoplasm

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

ClinicalTrials.gov processed this record on October 29, 2014