New chemo cocktail targets Hard-to-Treat testicular cancer
NCT ID NCT00183820
First seen Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time
Summary
This study tests a combination of three chemotherapy drugs—gemcitabine, oxaliplatin, and paclitaxel—in people with advanced testicular cancer that has not responded to standard cisplatin-based treatment or has returned after treatment. The goal is to see if this drug combination can shrink tumors or slow the disease. The trial enrolls about 30 adults with refractory germ cell tumors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- gemcitabine, oxaliplatin, and paclitaxel
- What this could lead to
- If successful, this combination could offer a new treatment option for patients with testicular cancer that has stopped responding to standard chemotherapy.
- What could go wrong
- This is a small, early-phase study, so the combination may not prove effective enough for wider use. Chemotherapy side effects are expected and can be serious.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
30 people
The number who actually took part.
- Start date
-
Nov 2004
- Finished
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Aug 2016
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
16 years and older
- Sex
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Male participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
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