Taxotere®, Eloxatin® and Xeloda® (TEX) in Combination With Herceptin® as Treatment for HER2 Positive Non-resectable Cancer
The primary aim of this dose-finding study is to determine the maximum tolerated dose of taxotere, eloxatin and capecitabine (TEX) in combination with herceptin given every third week as first-line treatment in patients with HER2-positive advanced gastro-esophageal cancer. Secondary end points are to evaluate progression-free survival and overall survival.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Dose Determination of Taxotere®, Eloxatin® and Xeloda® (TEX)in Combination With Herceptin® as First-line Treatment for Patients With HER2 Positive Non-resectable Oesophagus, Cardia or Gastric Cancer (ECV)|
- To determine maximum tolerable dose (MTD) for the combination regime TEX [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]The investigators have planned to examine 3 dose levels including 3 patients at each level with escalating doses of docetaxel from 42 mg/m² to 60 mg/m² and fixed doses of oxaliplatin (100 mg/m²), capecitabine 625 mg/m² x 2 and trastuzumab 6 mg/kg.
- Progression free survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]Time from inclusion to disease progression or death of any cause.
- Survival [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]Time from inclusion to death of any cause.
- Response rate [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]According to RECIST version 1.1.
|Study Start Date:||March 2011|
|Estimated Study Completion Date:||January 2015|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
42, 51 or 60 mg/m² day 1 every 3. week
Other Name: TaxotereDrug: Oxaliplatin
100 mg/m² day 1 every 3. week
Other Name: EloxatinDrug: Capecitabine
1250 mg/² continuously
Other Name: XelodaDrug: Trastuzumab
Trastuzumab 8 mg/kg day 1, cycle 1. Following cycles 6 mg/kg every 3. week
Other Name: Herceptin
To define the maximum tolerated dose of the combination of taxotere, eloxatin and capecitabine (TEX) in combination with herceptin given every third week as first- line treatment in patients with HER2-positive advanced gastro-esophageal cancer.
Estimating response-rate, progression free survival and overall survival
This dose-finding study is planned to include 15 patients with HER2 positive gastro-esophageal cancer, adenocarcinoma. Patients will be included in cohorts of three at progressively higher dose levels.
Chemotherapy will be repeated day 1 every third week to a maximum of eight cycles. Treatment with trastuzumab will continue until disease progression. Dose-limiting toxicity (DLT) will be evaluated after the first cycle. In case of DLT among one of the three patients during the first course of treatment additional three patients will be added at the respective dose level. Dose escalation is continued if 0/3 or 1/6 patients experience DLT.
Patients will be evaluated with a ct- scan at baseline and after every three cycles to exclude progression and evaluate response. Response is assessed by investigators according to RECIST version 1.1.
Blood counts regarding tumour biology will be collected at baseline before 2nd, 4th and 7th cycle and 4 weeks after ended treatment. After completion of treatment patients will be followed every third month until progression or death.
|Contact: Per Pfeiffer, Professor||+45 6541 firstname.lastname@example.org|
|Contact: Katrine Rahbek Schønnemann, MD||+45 6541 email@example.com|
|Aalborg University Hospital||Recruiting|
|Aalborg, Denmark, 9100|
|Contact: Mette Yilmaz, MD +45 9932 1111|
|Principal Investigator: Mette Yilmaz, MD|
|Aarhus University Hospital||Not yet recruiting|
|Aarhus, Denmark, 8000|
|Contact: Morten Ladekarl, MD +45 8949 4444|
|Principal Investigator: Morten Ladekarl, MD|
|Copenhagen, Denmark, 2100|
|Contact: Lene Bæksgaard, MD +45 3545 3545|
|Principal Investigator: Lene Bæksgaard, MD|
|Odense University Hospital||Recruiting|
|Odense, Denmark, 5000|
|Contact: Katrine Rahbek Schoennemann, MD +45 6541 2921 firstname.lastname@example.org|
|Principal Investigator: Katrine Rahbek Schoennemann, MD|
|Study Chair:||Per Pfeiffer, Professor||Odense University Hospital|