The Efficacy and Safety of Gemcitabine in Combination With Docetaxel to Treat Pancreatic or Biliary Cancer

National Trial Phase II to Study the Combination of Gemcitabine and Docetaxel in Patients With Locally Advanced or Metastatic Pancreatic or Biliary Adenocarcinoma That Cannot be Removed by Surgery

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00268840

Enrollment

Registered

2005-12-23

Start date

2001-08-31

Completion date

2006-02-28

Last updated

2011-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary Tract Neoplasms, Pancreatic Neoplasms

Keywords

Pancreas or biliary cancer

Brief summary

The purpose of this study is to assess the efficacy of combination therapy with gemcitabine and docetaxelin in patients with locally advanced or metastatic pancreatic or biliary adenocarcinoma.

Detailed description

Try a new drug association on this advanced cancer

Interventions

DRUGDocetaxel

Docetaxel 50 mg/m2 ou 35 mg/m² (suivant le bilan hépatique) à J1 et J15 toutes les 4 semaines

DRUGGemcitabine

Gemcitabine 1200 mg/m2 à J1 et J15 toutes les 4 semaines

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

* Patients aged 18 years or older * Patients must sign informed consent prior to study entry * Patients has Karnofsky performance status of more than 50% * No prior chemotherapy * Histologically or cytologically confirmed adenocarcinoma of the pancreas, locally advanced or metastatic disease or biliary cancer * No previous radiotherapy for locally advanced or metastases. * Hematopoietic: WBC \> 3000/mm2, Absolute neutrophile count \> 1500/mm2, Hemoglobin \> 9g/dl, Platelet count \> 100 000/mm2

Exclusion criteria

* No intracerebral or meningeal metastases * Pregnant * Fertile patient must use effective contraception * No other serious medical condition or illness that would preclude study participation * Hepatic: Bilirubin greater than upper limit of normal(ULN) SGOT and SGPT \> 3.5 times upper limit of normal(ULN) alkaline phosphatase \> 6 times upper limit of normal(ULN) * More than 30 days since prior investigational therapy

Design outcomes

Primary

Measure	Time frame
Overall response rate	—

Secondary

Measure	Time frame
Progression-free survival	—
Overall survival	—
To evaluate the frequency and severity of the adverse events related to the combination of gemcitabine and docetaxel	—
Clinical benefit	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026