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

June 5, 2026 updated by: University of Southern California

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Norris Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: paclitaxel, gemcitabine, and oxaliplatin
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor Response
Time Frame: From start of study drug until the date of first documented progression or date of death from any cause, whichever came first, assessed every 6 weeks, through study completion, up to 9 years
Defined as the best response recorded from the start of treatment until disease progression/recurrence, evaluated according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1 for target lesions and assessed by MRI: Complete Response (CR) = Disappearance of all target lesions; Partial Response (PR) = at least a 30% decrease in the sum of the diameters of the target lesions compared to the baseline; Stable Disease = Neither enough shrinkage for PR nor enough growth for PD; Progressive Disease = at least a 20% increase in the sum of the diameters of the target lesions from the smallest measurement recorded, with an absolute increase of at least 5 mm, or the appearance of one or more new lesions.
From start of study drug until the date of first documented progression or date of death from any cause, whichever came first, assessed every 6 weeks, through study completion, up to 9 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival
Time Frame: Through study completion, about 9 years
Progression-free survival measures the length of time a patient with cancer does not experience disease progression or death.
Through study completion, about 9 years
Overall Survival
Time Frame: Through study completion, about 9 years
Measuring Overall Survival
Through study completion, about 9 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Collaborators

Sanofi

Investigators

  • Principal Investigator: David Quinn, MD, University of Southern California

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimated)

September 16, 2005

Study Record Updates

Last Update Posted (Actual)

July 1, 2026

Last Update Submitted That Met QC Criteria

June 5, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4T-03-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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