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

NCT00183820 | Completed Phase 2

• 1 other identifier: 4T-03-1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Testicular; Extra gonadal germ cell neoplasm

Outcome Measures

Primary Outcomes (1)

• Tumor Response

  Every 6 weeks

Secondary Outcomes (1)

• Progression

  Every 9 wks

Study Arms (1)

1

EXPERIMENTAL

Drug: paclitaxel, gemcitabine, and oxaliplatin

Interventions

paclitaxel, gemcitabine, and oxaliplatin 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

1

Eligibility Criteria

• Age: 16 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• Sanofi: collaborator

Study Sites (1)

Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Testicular Neoplasms; Neoplasms, Germ Cell and Embryonal

Interventions

Paclitaxel; Gemcitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes

Study Officials

• David Quinn, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 16, 2005
• Study Start: November 1, 2004
• Primary Completion: December 1, 2015
• Study Completion: August 1, 2016
• Last Updated: July 7, 2017

Record last verified: 2017-07

Locations

US (1)