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OpenTrials
Completed

NCT Number: NCT00268840

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

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.

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Key information

Conditions

Pancreatic Neoplasms Biliary Tract Diseases Biliary Tract Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hôpital Hôtel Dieu

Paris, 75004, France

About this study

Try a new drug association on this advanced cancer

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

docetaxel

Drug

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

Other names: TAXOTERE

Gemcitabine

Drug

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

Other names: GEMZAR

Primary outcomes

  1. Overall response rate

Secondary outcomes

  1. Clinical benefit

  2. Progression-free survival

  3. Overall survival

  4. To evaluate the frequency and severity of the adverse events related to the combination of gemcitabine and docetaxel

Sponsors and collaborators

Lead sponsor

ARCAGY/ GINECO GROUP

Other

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2006
Study completion
2006
First posted
Dec 23, 2005
Registry last updated
Jun 30, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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