Clinical trial · Interventional
Study of Gemcitabine, Oxaliplatin, and Paclitaxel in Patients With Refractory Germ Cell Carcinoma
A Phase II Study of Gemcitabine, Oxaliplatin, and Paclitaxel in Patients With Refractory Germ Cell Carcinoma
NCT00183820CI-TRIAL-00116535completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Germ Cell Neoplasm | Germ Cell Tumor | ALIAS | 0.90 |
| Testicular Cancer | Malignant Testicular Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| paclitaxel, gemcitabine, and oxaliplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- paclitaxel, gemcitabine, and oxaliplatin
- interventionNames
- Drug: paclitaxel, gemcitabine, and oxaliplatin
Primary outcomes (1)
- measure
- Tumor Response
- timeFrame
- 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
- description
- 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.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 16 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.