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

Primary Purpose

Testicular Cancer, Germ Cell Neoplasm

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
paclitaxel, gemcitabine, and oxaliplatin
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Testicular Cancer focused on measuring Testicular, Extra gonadal germ cell neoplasm

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Prior histologic or serologic confirmation of testicular or extragonadal germ cell neoplasm not amenable to surgical cure 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 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. X-rays, scans, or PE for non-measurable dz must have been completed within 14 days of registration 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 Zubrod PS less than or equal to 2 Greater than or equal to 16 years of age AGC greater than or equal to 1.5; platelets greater than or equal to 100,000 Total bilirubin < 2.5 x uln; SGOT and alk phos < 5 x uln (obtained within 14 days prior to registration) LDH (obtained within 7 days prior to registration) 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) Serum K+ and Mg++ within inst range of normal (obtained within 14 days prior to registration) Men of reproductive potential must agree to use effective contraceptive method Signed informed consent (including HIPAA authorization) Exclusion Criteria: Prior tx with cytotoxic or experimental agents within 14 days prior to registration Evidence of concurrent infection (T > 96.8F but < 101.5F; WBC < 11.0 unless these values can be ascribed to another tumor-related phenomena) 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

Sites / Locations

  • Norris Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Tumor Response

Secondary Outcome Measures

Progression

Full Information

First Posted
September 9, 2005
Last Updated
July 5, 2017
Sponsor
University of Southern California
Collaborators
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00183820
Brief Title
Study of Gemcitabine, Oxaliplatin, and Paclitaxel in Patients With Refractory Germ Cell Carcinoma
Official Title
A Phase II Study of Gemcitabine, Oxaliplatin, and Paclitaxel in Patients With Refractory Germ Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern California
Collaborators
Sanofi

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Testicular Cancer, Germ Cell Neoplasm
Keywords
Testicular, Extra gonadal germ cell neoplasm

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
paclitaxel, gemcitabine, and oxaliplatin
Intervention Description
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
Primary Outcome Measure Information:
Title
Tumor Response
Time Frame
Every 6 weeks
Secondary Outcome Measure Information:
Title
Progression
Time Frame
Every 9 wks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Prior histologic or serologic confirmation of testicular or extragonadal germ cell neoplasm not amenable to surgical cure 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 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. X-rays, scans, or PE for non-measurable dz must have been completed within 14 days of registration 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 Zubrod PS less than or equal to 2 Greater than or equal to 16 years of age AGC greater than or equal to 1.5; platelets greater than or equal to 100,000 Total bilirubin < 2.5 x uln; SGOT and alk phos < 5 x uln (obtained within 14 days prior to registration) LDH (obtained within 7 days prior to registration) 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) Serum K+ and Mg++ within inst range of normal (obtained within 14 days prior to registration) Men of reproductive potential must agree to use effective contraceptive method Signed informed consent (including HIPAA authorization) Exclusion Criteria: Prior tx with cytotoxic or experimental agents within 14 days prior to registration Evidence of concurrent infection (T > 96.8F but < 101.5F; WBC < 11.0 unless these values can be ascribed to another tumor-related phenomena) 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Quinn, MD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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