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AzTrials

Esophageal CancerPhase 1/2NCT00445861

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

A Phase 1/2 study testing cetuximab + docetaxel + cisplatin, Treatment level 1 and Treatment level 2 in people with Esophageal Cancer, run by Swiss Cancer Institute at 2 sites in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Esophageal Cancer
What is being tested?
cetuximab + docetaxel + cisplatin, Treatment level 1 and Treatment level 2
How many people
27 participants
Where
2 sitesSwitzerland
Study dates
Jan 2007to Nov 2008
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

2 sites in 1 country.

Switzerland2 sites

  • Kantonsspital - St. Gallen

    Sankt Gallen, CH-9007

  • Klinik Stephanshorn

    Sankt Gallen, Ch-9016

Other trials in Switzerland

About this study

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

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.

Read the 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.

Being tested
cetuximab + docetaxel + cisplatin, Treatment level 1, Treatment level 2, conventional surgery
Keywords
adenocarcinoma of the esophagus, squamous cell carcinoma of the esophagus, stage II esophageal cancer, stage III esophageal cancer
Medical subject headings
Esophageal Neoplasms, Adenocarcinoma Of Esophagus, Esophageal Squamous Cell Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cetuximab + docetaxel + cisplatinBiological

    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 1Biological

    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 2Biological

    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 surgeryProcedure or surgery

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Until treatment ends

Secondary outcomes (2)

  1. Determine the feasibility and efficacy of the study's regimen

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

    Measured: Until trial ends

  2. Determine the duration of response and patterns of failure

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

    Measured: Until trial ends

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2007 (estimated)
  2. Study startJan 2007
  3. Primary completionNov 2008
  4. Study completionNov 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00445861
Sponsor's protocol ID
SAKK 75/06
Other IDs
EU-20702
Status last verified
Jun 2012
First submitted
7 Mar 2007
Last updated
11 Jun 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 21205757

  • 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.

    PubMed 28742685

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing cetuximab + docetaxel + cisplatin, Treatment level 1 and Treatment level 2 in people with Esophageal Cancer, run by Swiss Cancer Institute at 2 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine the safety of neoadjuvant radiotherapy in combination with cetuximab, docetaxel, and cisplatin (time frame: Until treatment ends). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00445861, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2012.

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