Clinical trial · Interventional
Docetaxel Plus Oxaliplatin as Therapy in Patients With Pancreatic Cancer
Phase II Study: Docetaxel Plus Oxaliplatin as Second-line Therapy in Patients With Advanced Metastatic Pancreatic Cancer
NCT00690300CI-TRIAL-00003233unknownPhase 2ClinicalTrials.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)
The purpose of this study is to test a combination-therapy of oxaliplatin and docetaxel in patients with metastatic or locally advanced adenocarcinoma of the pancreas after failure of a palliative first line therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreas Neoplasms | Pancreatic Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- tumor response
- timeFrame
- 12/2009 and end of the study 12/2010
Secondary outcomes (5)
- measure
- progression free survival
- timeFrame
- 12/2009 and end of study 12/2010
- measure
- overall survival
- timeFrame
- 12/2009 and end of study 12/2010
- measure
- Questionnaire for quality of life
- timeFrame
- every three weeks
- measure
- Questionnaire for clinical Benefit
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Dated and signed informed concent * Histologically or cytologically proven metastatic or locally advanced adenocarcinoma of the exocrine pancreas (stadium UICC III/IV) * Presence of at least one measurable (according to RECIST criteria) marker lesion (primary tumor or metastasis) outside of an area that was previously subjected to radiation therapy * Failure of a palliative first line therapy of a metastatic or locally advanced adenocarcinoma of the exocrine pancreas due to: Progress within 3 months after a first-line therapy Discontinuation of a first-line therapy due to toxicity * Age \>= 18 years * Karnofsky index \> 60% * Expected live span \> 12 weeks * Sufficient bone marrow reserve: Granulocytes \>= 1.5 x 109/L and Platelets \>= 100 x 109/L and Hemoglobin \>= 9 g/L * Serum Bilirubin \< 2 x upper normal limit or 2.5 x upper normal limit in case of hepatic metastasis (biliary drainage allowed) * AST/ALT \< 2.5 x upper normal limit Exclusion Criteria: * Every other cancer or secondary cancer besides the basal cell carcinoma of the skin or the carcinoma in situ of the cervix uteri. Inclusion of patients with other types of cancer that were successfully treated and that did not relapse within the last 5 years is possible * Pregnancy or lactation * Patients able to reproduce that do not adhere to strict contraception * Presence of brain metastasis * Severe, uncontrolled infection * Preexisting peripheral neuropathy \> grade I * Preexisting severe illnesses such as unstable coronary artery disease or uncontrolled cardiac arrhythmia * Justified disbelief in the compliance of the patient * Parallel participation in another clinical trial
References
Publications (1)
- DERIVEDEttrich TJ, Perkhofer L, von Wichert G, Gress TM, Michl P, Hebart HF, Buchner-Steudel P, Geissler M, Muche R, Danner B, Kachele V, Berger AW, Guthle M, Seufferlein T. DocOx (AIO-PK0106): a phase II trial of docetaxel and oxaliplatin as a second line systemic therapy in patients with advanced pancreatic ductal adenocarcinoma. BMC Cancer. 2016 Jan 15;16:21. doi: 10.1186/s12885-016-2052-4. PMID 26772812