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

NCT00445861 | Completed Phase 1 DMC

• 2 other identifiers: SAKK 75/06EU-20702
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 2

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.

Conditions

Esophageal Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

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

  Until treatment ends

Secondary Outcomes (2)

• Determine the feasibility and efficacy of the study's regimen

  Until trial ends

• Determine the duration of response and patterns of failure

  Until trial ends

Interventions

cetuximab + docetaxel + cisplatin BIOLOGICAL

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.

Treatment level 1 BIOLOGICAL

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 BIOLOGICAL

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.

conventional surgery PROCEDURE

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Swiss Cancer Institute: lead

Study Sites (2)

Kantonsspital - St. Gallen

Sankt Gallen, CH-9007, Switzerland

Location

Klinik Stephanshorn

Sankt Gallen, Ch-9016, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 21205757 RESULT

• 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.

  PMID: 28742685 DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms; Adenocarcinoma Of Esophagus; Esophageal Squamous Cell Carcinoma

Interventions

Cetuximab; Docetaxel; Cisplatin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Thomas Ruhstaller, MD

  Cantonal Hospital of St. Gallen

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2007
• First Posted: March 9, 2007
• Study Start: January 1, 2007
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: June 11, 2012

Record last verified: 2012-06

Locations

CH (2)