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Cetuximab, Docetaxel, Cisplatin, and Radiation Therapy in Treating Patients With Locally Advanced Esophageal Cancer That Can Be Removed by Surgery

Primary Purpose

Esophageal Cancer

Status

Completed

Phase

Phase 1

Locations

Switzerland

Study Type

Interventional

Intervention

cetuximab + docetaxel + cisplatin

Treatment level 1

Treatment level 2

conventional surgery

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring adenocarcinoma of the esophagus, squamous cell carcinoma of the esophagus, stage II esophageal cancer, stage III esophageal cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

Histologically confirmed squamous cell carcinoma or adenocarcinoma of the thoracic esophagus
- Carcinoma of the gastroesophageal junction (i.e., Siewert staging system type I disease) allowed
Locally advanced disease
- Obstructive tumors are considered locally advanced disease
- Meets 1 of the following staging criteria:
  - T3, N0 disease
  - T1-3, N1 disease
  - T4, N0-1 disease
Resectable disease
- No T4 (unequivocal organ involvement) disease that cannot be resected with curative intent
No airway infiltration in case of tumors of the upper third of the thoracic esophagus
No cervical esophageal carcinoma
No distant metastasis, including stage M1a (celiac node involvement) by fine-needle aspiration or biopsy

PATIENT CHARACTERISTICS:

WHO performance status 0-1
Creatinine clearance > 60 mL/min
Bilirubin normal
Alkaline phosphatase ≤ 2.5 times upper limit of normal (ULN)
AST ≤ 1.5 times ULN
Absolute neutrophil count ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 12 months after completion of study treatment
No other malignancy within the past 5 years except nonmelanomatous skin cancer or adequately treated in situ cervical cancer
No severe or uncontrolled cardiovascular disease including, but not limited to, any of the following:
- New York Heart Association class III or IV congestive heart failure
- Unstable angina pectoris
- Myocardial infarction within the past 3 months
- Significant arrhythmias
No psychiatric disorder that would preclude study compliance
No active uncontrolled infection
No serious underlying medical condition that, in the opinion of the investigator, would interfere with study participation (e.g., uncontrolled diabetes mellitus or active autoimmune disease)
No peripheral neuropathy > grade 1
No contraindications to corticosteroids
No known hypersensitivity to any component of the study drugs

PRIOR CONCURRENT THERAPY:

No prior chemotherapy
No prior radiotherapy to the chest
No participation in another clinical trial within the past 30 days
No other concurrent experimental drugs or anticancer therapy
No concurrent drugs contraindicated for use with the study drugs

Sites / Locations

Kantonsspital - St. Gallen
Klinik Stephanshorn

Outcomes

Primary Outcome Measures

Determine the safety of neoadjuvant radiotherapy in combination with cetuximab, docetaxel, and cisplatin

Secondary Outcome Measures

Determine the feasibility and efficacy of the study's regimen

Determine the feasibility and efficacy of this regimen in these patients.

Determine the duration of response and patterns of failure

Determine the duration of response and patterns of failure in patients treated with this regimen

Full Information

NCT ID

NCT00445861

First Posted

March 7, 2007

Last Updated

June 8, 2012

Sponsor

Swiss Group for Clinical Cancer Research

1. Study Identification

Unique Protocol Identification Number

NCT00445861

Brief Title

Cetuximab, Docetaxel, Cisplatin, and Radiation Therapy in Treating Patients With Locally Advanced Esophageal Cancer That Can Be Removed by Surgery

Official Title

Cetuximab in Combination With Radiation Therapy and Chemotherapy Prior to Surgery in Patients With Resectable, Locally Advanced Esophageal Carcinoma. A Multicenter Phase IB-II Trial

Study Type

Interventional

2. Study Status

Record Verification Date

June 2012

Overall Recruitment Status

Completed

Study Start Date

January 2007 (undefined)

Primary Completion Date

November 2008 (Actual)

Study Completion Date

November 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Swiss Group for Clinical Cancer Research

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving cetuximab, docetaxel, and cisplatin together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase I/II trial is studying the side effects of cetuximab, docetaxel, cisplatin, and radiation therapy and to see how well they work in treating patients with locally advanced esophageal cancer that can be removed by surgery.

Detailed Description

OBJECTIVES: Primary Determine the safety of neoadjuvant radiotherapy in combination with cetuximab, docetaxel, and cisplatin in patients with resectable locally advanced esophageal cancer. Secondary Determine the feasibility and efficacy of this regimen in these patients. Determine the duration of response and patterns of failure in patients treated with this regimen. OUTLINE: This is a multicenter study. Chemoimmunotherapy: Patients receive cetuximab IV over 1-2 hours once weekly in weeks 1-3 and docetaxel IV over 1 hour and cisplatin IV over 1 hour once in week 1. Treatment repeats every 3 weeks for 2 courses. Chemoimmunotherapy and radiotherapy: Patients are sequentially assigned to 1 of 2 treatment levels. Treatment level 1: Patients receive cetuximab IV over 1 hour once weekly, cisplatin IV over 1 hour once weekly, and undergo radiotherapy once daily, 5 days a week, in weeks 7-11. Treatment level 2: Patients receive cetuximab, cisplatin, and radiotherapy as in treatment level 1. Patients also receive docetaxel IV over 1-2 hours once weekly in weeks 7-11. Cohorts of 7-20 patients are treated at treatment level 1 or 2 sequentially, as long as no more than 2 of 7 patients experience dose-limiting toxicity (DLT), until the safe treatment level for future study is determined. The safe treatment level is defined as the level at which no more than 2 of 7 and no more than 6 of 20 patients experience DLT. At least 20 patients are treated at the safe treatment level. Surgery: Between 4-8 weeks after completion of neoadjuvant chemoimmunotherapy and radiotherapy, patients undergo surgery. After completion of study treatment, patients are followed every 3 months for 1 year, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Cancer

Keywords

adenocarcinoma of the esophagus, squamous cell carcinoma of the esophagus, stage II esophageal cancer, stage III esophageal cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

cetuximab + docetaxel + cisplatin

Intervention Description

Chemoimmunotherapy: Patients receive cetuximab IV over 1-2 hours once weekly in weeks 1-3 and docetaxel IV over 1 hour and cisplatin IV over 1 hour once in week 1. Treatment repeats every 3 weeks for 2 courses.

Intervention Type

Biological

Intervention Name(s)

Treatment level 1

Intervention Description

Treatment level 1: Patients receive cetuximab IV over 1 hour once weekly, cisplatin IV over 1 hour once weekly, and undergo radiotherapy once daily, 5 days a week, in weeks 7-11.

Intervention Type

Biological

Intervention Name(s)

Treatment level 2

Intervention Description

Patients receive cetuximab, cisplatin, and radiotherapy as in treatment level 1. Patients also receive docetaxel IV over 1-2 hours once weekly in weeks 7-11.

Intervention Type

Procedure

Intervention Name(s)

conventional surgery

Intervention Description

Between 4-8 weeks after completion of neoadjuvant chemoimmunotherapy and radiotherapy, patients undergo surgery.

Primary Outcome Measure Information:

Title

Determine the safety of neoadjuvant radiotherapy in combination with cetuximab, docetaxel, and cisplatin

Description

Determine the safety of neoadjuvant radiotherapy in combination with cetuximab, docetaxel, and cisplatin

Time Frame

Until treatment ends

Secondary Outcome Measure Information:

Title

Determine the feasibility and efficacy of the study's regimen

Description

Determine the feasibility and efficacy of this regimen in these patients.

Time Frame

Until trial ends

Title

Determine the duration of response and patterns of failure

Description

Determine the duration of response and patterns of failure in patients treated with this regimen

Time Frame

Until trial ends

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

DISEASE CHARACTERISTICS: Histologically confirmed squamous cell carcinoma or adenocarcinoma of the thoracic esophagus Carcinoma of the gastroesophageal junction (i.e., Siewert staging system type I disease) allowed Locally advanced disease Obstructive tumors are considered locally advanced disease Meets 1 of the following staging criteria: T3, N0 disease T1-3, N1 disease T4, N0-1 disease Resectable disease No T4 (unequivocal organ involvement) disease that cannot be resected with curative intent No airway infiltration in case of tumors of the upper third of the thoracic esophagus No cervical esophageal carcinoma No distant metastasis, including stage M1a (celiac node involvement) by fine-needle aspiration or biopsy PATIENT CHARACTERISTICS: WHO performance status 0-1 Creatinine clearance > 60 mL/min Bilirubin normal Alkaline phosphatase ≤ 2.5 times upper limit of normal (ULN) AST ≤ 1.5 times ULN Absolute neutrophil count ≥ 1,500/mm³ Platelet count ≥ 100,000/mm³ Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 12 months after completion of study treatment No other malignancy within the past 5 years except nonmelanomatous skin cancer or adequately treated in situ cervical cancer No severe or uncontrolled cardiovascular disease including, but not limited to, any of the following: New York Heart Association class III or IV congestive heart failure Unstable angina pectoris Myocardial infarction within the past 3 months Significant arrhythmias No psychiatric disorder that would preclude study compliance No active uncontrolled infection No serious underlying medical condition that, in the opinion of the investigator, would interfere with study participation (e.g., uncontrolled diabetes mellitus or active autoimmune disease) No peripheral neuropathy > grade 1 No contraindications to corticosteroids No known hypersensitivity to any component of the study drugs PRIOR CONCURRENT THERAPY: No prior chemotherapy No prior radiotherapy to the chest No participation in another clinical trial within the past 30 days No other concurrent experimental drugs or anticancer therapy No concurrent drugs contraindicated for use with the study drugs

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas Ruhstaller, MD

Organizational Affiliation

Cantonal Hospital of St. Gallen

Official's Role

Study Chair

Facility Information:

Facility Name

Kantonsspital - St. Gallen

City

St. Gallen

ZIP/Postal Code

CH-9007

Country

Switzerland

Facility Name

Klinik Stephanshorn

City

St. Gallen

ZIP/Postal Code

Ch-9016

Country

Switzerland

12. IPD Sharing Statement

Citations:

PubMed Identifier

21205757

Citation

Ruhstaller T, Pless M, Dietrich D, Kranzbuehler H, von Moos R, Moosmann P, Montemurro M, Schneider PM, Rauch D, Gautschi O, Mingrone W, Widmer L, Inauen R, Brauchli P, Hess V. Cetuximab in combination with chemoradiotherapy before surgery in patients with resectable, locally advanced esophageal carcinoma: a prospective, multicenter phase IB/II Trial (SAKK 75/06). J Clin Oncol. 2011 Feb 20;29(6):626-31. doi: 10.1200/JCO.2010.31.9715. Epub 2011 Jan 4.

Results Reference

result

PubMed Identifier

28742685

Citation

Steffen T, Dietrich D, Schnider A, Kettelhack C, Huber O, Marti WR, Furrer M, Gloor B, Schiesser M, Thierstein S, Brauchli P, Ruhstaller T; Swiss Group for Clinical Cancer Research (SAKK). Recurrence Patterns and Long-term Results After Induction Chemotherapy, Chemoradiotherapy, and Curative Surgery in Patients With Locally Advanced Esophageal Cancer. Ann Surg. 2019 Jan;269(1):83-87. doi: 10.1097/SLA.0000000000002435.

Results Reference

derived

Learn more about this trial

Cetuximab, Docetaxel, Cisplatin, and Radiation Therapy in Treating Patients With Locally Advanced Esophageal Cancer That Can Be Removed by Surgery

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