Taxotere®, Eloxatin® and Xeloda® (TEX) in Combination With Herceptin® as Treatment for HER2 Positive Non-resectable Cancer

Adenocarcinoma Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01295086
• Other study ID #: Her-TEX
• Status: Completed
• Phase: N/A
• Start date: March 2011
• Est. completion date: January 2018

Study information

• Verified date: October 2020
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Primary aim:

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.

Secondary aims:

Estimating response-rate, progression free survival and overall survival

Methods:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: January 2018
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Patients with histologically proven ECV-adenocarcinoma, non-resectable or metastatic disease

2. HER2-positive tumor tissue (IHC 3 + or FISH positive)

3. LVEF > 50 % (MUGA scan or echocardiography)

4. Age = 18 years

5. No prior chemotherapy

6. WHO performance status 0-1

7. Life expectancy of at least 3 months

8. Neutrophils = 1.5 x 109/L and platelets = 100 x 109/L

9. Bilirubin = 1.5 x UNL (Upper Normal Limit) and ASAT and/or ALAT = 3 x UNL. In case of liver metastases no UNL for ASAT and ALAT

10. Creatinine clearance = 50 ml/min. Calculated with the Cockroft-Gault formula

11. No neuropathy

12. Planned treatment start within 8 days after inclusion

Exclusion Criteria:

1. Patients who cannot complete treatment or evaluation

2. Any condition or treatment which after the opinion of the investigator may expose the patients to a risc or influence the purpose of the study

3. Known hypersensitivity towards any of the study drugs

4. Other malignant disease within the last 5 days, except for non-melanoma skin cancer

5. Other serious disease (e.g. cardiac disease, AMI within 1 year or infection)

6. Pregnant women or nursing women

7. Physical or mental conditions which may prevent absorption of oral treatment

Related Conditions & MeSH terms

• Adenocarcinoma

Intervention

Drug:
• Docetaxel
42, 51 or 60 mg/m² day 1 every 3. week
• Oxaliplatin
100 mg/m² day 1 every 3. week
• Capecitabine
1250 mg/² continuously
• Trastuzumab
Trastuzumab 8 mg/kg day 1, cycle 1. Following cycles 6 mg/kg every 3. week

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg
Denmark	Aarhus University Hospital	Aarhus
Denmark	Rigshospitalet	Copenhagen
Denmark	Odense University Hospital	Odense

Sponsors (4)

Lead Sponsor	Collaborator
Odense University Hospital	Aalborg University Hospital, Aarhus University Hospital, Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine maximum tolerable dose (MTD) for the combination regime TEX	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.	2 years
Secondary	Progression free survival	Time from inclusion to disease progression or death of any cause.	3 years
Secondary	Survival	Time from inclusion to death of any cause.	4 years
Secondary	Response rate	According to RECIST version 1.1.	3 years