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

NCT ID: NCT00183820

Last Updated: 2017-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-11-30
• Study Completion Date: 2016-08-31

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.

Conditions

Testicular Cancer; Germ Cell Neoplasm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

paclitaxel, gemcitabine, and oxaliplatin

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 16 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Quinn, MD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

Norris Comprehensive Cancer Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

4T-03-1

Identifier Type: -

Identifier Source: org_study_id