Phase 1
Completed N=21
Capecitabine, Docetaxel and Gemcitabine in Patients With Advanced Pancreas Cancer
Source: ClinicalTrials.gov NCT00320749 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Oct 2015
Primary outcomePrimary: Maximum Tolerated Dose (MTD) — 36; 750; 625 mg/m^2
Summary
The primary purpose of this study is to define the maximum tolerated dose of combination docetaxel, gemcitabine, and capecitabine in patients with pancreatic cancer. Adverse effects will be measured in study participants. In addition, researchers will assess data about preliminary efficacy in patients with this treatment approach.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose (MTD) |
36; 750; 625 | — |
| SECONDARY Common Toxicities |
29; 29; 25 | — |
| SECONDARY Therapeutic Response |
11; 0; 72 | — |
Eligibility Criteria
Inclusion Criteria
- adenocarcinoma of the pancreas
- no prior chemo except adjuvant
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- peripheral neuropathy </= Gr. 1
Exclusion Criteria
- Pregnant/lactating females
- Uncontrolled heart disease, diabetes, psychiatric disorder
- Therapeutic doses of Warfarin
Data sourced from ClinicalTrials.gov (NCT00320749). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.