Docetaxel and Oxaliplatin in Gastric Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00382720
First received: September 27, 2006
Last updated: December 19, 2012
Last verified: December 2012
  Purpose

This phase II study addressed the use of docetaxel in combination with oxaliplatin with or without 5-FU or capecitabine in metastatic or locally recurrent gastric cancer previously untreated with chemotherapy for advanced disease. Prior to this study a pilot phase I (part I) determined the optimal dose by assessing the safety and tolerability of 2 dose levels in each arm. The optimal dose was administered in the Part II study. Participants who received the optimal dose in each treatment arm in Part I were included in the Part II analysis population.

Primary objective:

  • To assess the time to progression (TTP) of Docetaxel in combination with Oxaliplatin with or without 5-Fluorouracil (5-FU) or Capecitabine in metastatic or locally recurrent gastric cancer previously untreated with chemotherapy for advanced disease (part II).

Secondary objectives:

  • To establish the safety profile.
  • To assess the Overall Response Rate (ORR) based on the World Health Organization (WHO) criteria
  • To assess the Overall Survival (OS)

Condition Intervention Phase
Stomach Neoplasms
Drug: Docetaxel + Oxaliplatin
Drug: Docetaxel + Oxaliplatin + 5-FU
Drug: Docetaxel + Oxaliplatin + Capecitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study of Docetaxel in Combination With Oxaliplatin With or Without 5-FU or Capecitabine in Metastatic or Locally Recurrent Gastric Cancer Previously Untreated With Chemotherapy for Advanced Disease

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Time to Progression [ Time Frame: every 8 weeks up to a maximum of 36 months ] [ Designated as safety issue: No ]

    The number of months measured from the day of randomization to the first tumor progression according to World Health Organization (WHO) criteria evaluation of cancer response, or death from any cause.

    WHO Criteria for Progressive Disease: ≥ 25% increase in the size of at least one bidimensionally or unidimensionally measurable lesion.



Secondary Outcome Measures:
  • Best Overall Response Rate (ORR) [ Time Frame: every 8 weeks up to a maximum of 36 months ] [ Designated as safety issue: No ]

    Percentage of partial and complete responses, according to WHO criteria:

    Complete Response: Disappearance of all known disease, determined by 2 observations not less than 4 weeks apart.

    Partial Response: Decrease by at least 50% of the diameters of all measurable lesions, determined by 2 observations not less than 4 weeks apart.


  • Overall Survival (OS) [ Time Frame: up to a maximum of 36 months ] [ Designated as safety issue: No ]
    The number of months measured from the date of randomization to the date of death due to any cause.


Enrollment: 275
Study Start Date: September 2006
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TE (Taxotere and Eloxatin)

Docetaxel (Taxotere) in combination with Oxaliplatin (Eloxatin). Each chemotherapy cycle was repeated every 21 days.

Participants received either the optimal or non-optimal dose for Taxotere and Eloxatin. Participants who received the optimal dose for Taxotere and Eloxatin were analyzed in this study.

Drug: Docetaxel + Oxaliplatin

Dose level 1 (non-optimal dose):

Docetaxel 75 mg/m² as an 1-hour intravenous (IV) infusion on day 1 followed by Oxaliplatin 100 mg/m² as a two to six-hour IV infusion on day 1

Dose level 2 (optimal dose):

Docetaxel 75 mg/m² as an 1-hour IV infusion on day 1 followed by Oxaliplatin 130 mg/m² as a two to six-hour IV infusion on day 1

Experimental: TEF (Taxotere, Eloxatin and 5-FU)

Docetaxel (Taxotere) in combination with Oxaliplatin (Eloxatin) and 5-FU (5-Fluorouracil). Each chemotherapy cycle was repeated every 14 days.

Participants received either the optimal or non-optimal dose for Taxotere, Eloxatin and 5-FU. Participants who received the optimal dose for Taxotere, Eloxatin and 5-FU were analyzed in this study.

Drug: Docetaxel + Oxaliplatin + 5-FU

Dose level 1 (non-optimal dose):

Docetaxel 40 mg/m² as a 1-hour intravenous (IV) infusion day 1; Oxaliplatin 85 mg/m² simultaneously with folinic acid 400 mg/m² as a 2-hour IV infusion, followed by 5-FU 2400 mg/m2 as a 46-hour continuous infusion day 1.

Dose level 2 (optimal dose):

Docetaxel 50 mg/m² as a 1-hour IV infusion day 1; Oxaliplatin 85 mg/m² simultaneously with folinic acid 400 mg/m² as a 2-hour IV infusion, followed by 5-FU 2400 mg/m² as a 46-hour continuous infusion day 1.

Experimental: TEX (Taxotere, Eloxatin and Xeloda)

Docetaxel (Taxotere) in combination with Oxaliplatin (Eloxatin) and capecitabine (Xeloda). Each chemotherapy cycle was repeated every 21 days.

Participants received either the optimal or non-optimal dose for Taxotere, Eloxatin and Xeloda. Participants who received the optimal dose for Taxotere, Eloxatin and Xeloda were analyzed in this study.

Drug: Docetaxel + Oxaliplatin + Capecitabine

Dose level 1 (optimal dose):

Docetaxel 50 mg/m² as a 1-hour intravenous (IV) infusion on day 1, Oxaliplatin 100 mg/m² as a two to six-hour IV infusion on day 1, Capecitabine 625 mg/m2 two times a day continuously.

Dose level 2 (non-optimal dose):

Docetaxel 65 mg/m² as a 1-hour IV infusion on day 1, Oxaliplatin 100 mg/m² as a two to six-hour IV infusion on day 1, Capecitabine 625 mg/m² two times a day continuously.


Detailed Description:

The purpose of this study (Part II) was to evaluate the time to progression in the 3 arms at an optimal dose level of docetaxel and oxaliplatin defined during a prior pilot (Part I) phase study. The estimated duration of treatment was to be 6 months. Treatment was to be administered up to progression, unacceptable toxicities, or withdrawal of consent. The reason and date of removal of all participants was documented on the case report form.

Participants who ended treatment but had not yet progressed (e.g. unacceptable toxicities or withdrawal of consent) were be followed every 8 weeks with a complete tumor assessment until documented progression or further anti-tumor therapy. Then, they would be followed every 3 months after progression for survival status; date of death or progression were reported. Participants who ended treatment for progression, were to be followed every 3 months until death. Date of death was reported. The planned duration of the study was 30 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Histologically proven gastric adenocarcinoma, including adenocarcinoma of the gastro-oesophageal junction
  • Metastatic or locally recurrent disease
  • Prior adjuvant (and/or neo-adjuvant) chemotherapy with 5-Fluorouracil, Cisplatin, epirubicin is allowed provided that the patient has relapsed > 12 months after the end of the chemotherapy
  • Performance status Karnofsky index > 70
  • Hematology within 7 days before randomization:Hemoglobin ≥10g/dl, Absolute Neutrophil Count ≥2.0 10^9/L, platelets ≥100 x 10^9/L
  • Blood chemistry within 7 days before randomization:Total bilirubin ≤1x Upper Normal Limit(UNL), Aspartate Aminotransferase (AST) Serum Glutamic Oxaloacetic Transaminase SGOT) and Alanine Aminotransferase (ALT)Serum Glutamate Pyruvate Transaminase(SGPT) ≤2.5xUNL, alkaline phosphatase ≤ 5x UNL, provided that AST or ALT > 1.5 x UNL is not associated with alkaline phosphatase > 2.5 x UNL; creatinine ≤1.25x UNL or 1.25x UNL < creatinine ≤1.5x UNL and calculated/measured creatinine clearance ≥60 ml/min)
  • Measurable and/or evaluable metastatic disease

Exclusion criteria:

  • Any prior palliative chemotherapy
  • Neurosensory symptoms National Cancer Institute Common Toxicity Criteria for Adverse Events grade≥2

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00382720

Locations
United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
Belgium
Sanofi-Aventis Administrative Office
Diegem, Belgium
France
Sanofi-Aventis Administrative Office
Paris, France
Germany
Sanofi-Aventis Administrative Office
Frankfurt, Germany
Hungary
Sanofi-Aventis Administrative Office
Budapest, Hungary
Italy
Sanofi-Aventis Administrative Office
Milan, Italy
Portugal
Sanofi-Aventis Administrative Office
Porto Salvo, Portugal
Russian Federation
Sanofi-Aventis Administrative Office
Moscow, Russian Federation
Spain
Sanofi-Aventis Administrative Office
Barcelona, Spain
Switzerland
Sanofi-Aventis Administrative Office
Genève, Switzerland
Turkey
Sanofi-Aventis Administrative Office
Istanbul, Turkey
United Kingdom
Sanofi-Aventis Administrative Office
Guildford Surrey, United Kingdom
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Jean-Philippe Aussel Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00382720     History of Changes
Other Study ID Numbers: DOCOX_C_00082, EudraCT # : 2005-005464-92
Study First Received: September 27, 2006
Results First Received: April 29, 2011
Last Updated: December 19, 2012
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

Additional relevant MeSH terms:
Neoplasms
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Fluorouracil
Capecitabine
Oxaliplatin
Docetaxel
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 28, 2014