Testicular CancerPhase 2NCT00183820
Study of Gemcitabine, Oxaliplatin, and Paclitaxel in Patients With Refractory Germ Cell Carcinoma
A Phase 2 study testing paclitaxel, gemcitabine, and oxaliplatin in people with Testicular Cancer and Germ Cell Neoplasm, run by University of Southern California at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older, men only
- Conditions the study is for
- Testicular Cancer, Germ Cell Neoplasm
- What is being tested?
- paclitaxel, gemcitabine, and oxaliplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to Aug 2016
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: 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.
- Conditions
- Testicular Cancer, Germ Cell Neoplasm
- Being tested
- paclitaxel, gemcitabine, and oxaliplatin
- Keywords
- Testicular, Extra gonadal germ cell neoplasm
- Medical subject headings
- Testicular Neoplasms, Neoplasms, Germ Cell and Embryonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paclitaxel, gemcitabine, and oxaliplatinDrug
- 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
| Study group | Role | What they receive |
|---|---|---|
| paclitaxel, gemcitabine, and oxaliplatin | Experimental | Not described Receives: Drug: paclitaxel, gemcitabine, and oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor Response
Defined as the best response recorded from the start of treatment until disease progression/recurrence, evaluated according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1 for target lesions and assessed by MRI: Complete Response (CR) = Disappearance of all target lesions; Partial Response (PR) = at least a 30% decrease in the sum of the diameters of the target lesions compared to the baseline; Stable Disease = Neither enough shrinkage for PR nor enough growth for PD; Progressive Disease = at least a 20% increase in the sum of the diameters of the target lesions from the smallest measurement recorded, with an absolute increase of at least 5 mm, or the appearance of one or more new lesions.
Measured: From start of study drug until the date of first documented progression or date of death from any cause, whichever came first, assessed every 6 weeks, through study completion, up to 9 years
Secondary outcomes (2)
Progression-Free Survival
Progression-free survival measures the length of time a patient with cancer does not experience disease progression or death.
Measured: Through study completion, about 9 years
Overall Survival
Measuring Overall Survival
Measured: Through study completion, about 9 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startNov 2004
- Primary completionDec 2015
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Testicular CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- David Quinn, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00183820
- Sponsor's protocol ID
- 4T-03-1
- Status last verified
- Jun 2026
- First submitted
- 9 Sep 2005
- Last updated
- 1 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov