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

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: Testicular Cancer; Germ Cell Neoplasm
• Intervention / Treatment: Drug: paclitaxel, gemcitabine, and oxaliplatin

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: paclitaxel, gemcitabine, and oxaliplatin; Paclitaxel 170 mg/m2 IV d 1 14 days; Gemcitabine 800 mg/m2 IV d 1 14 days; Oxaliplatin 100 mg/m2 IV d 1 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Tumor Response	Every 6 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Progression	Every 9 wks

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: Sanofi
• Investigators: Principal Investigator: David Quinn, MD, University of Southern California

Study record dates

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 (Estimate): September 16, 2005

Study Record Updates

• Last Update Posted (Actual): July 7, 2017
• Last Update Submitted That Met QC Criteria: July 5, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Testicular; Extra gonadal germ cell neoplasm
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Endocrine System Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Genital Neoplasms, Male; Testicular Diseases; Neoplasms, Germ Cell and Embryonal; Testicular Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Gemcitabine; Paclitaxel; Oxaliplatin
• Other Study ID Numbers: 4T-03-1