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

Sponsor

University of Southern California (Other)

Overall Status

Completed

CT.gov ID

NCT00183820

Collaborator

Sanofi (Industry)

Enrollment

Location

Arm

141

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Testicular Cancer Germ Cell Neoplasm	Drug: paclitaxel, gemcitabine, and oxaliplatin	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2004

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Aug 1, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Tumor Response [Every 6 weeks]

Secondary Outcome Measures

Progression [Every 9 wks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

Male

Accepts 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