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Esophageal CancerPhase 1/2NCT00425425

Cetuximab, Oxaliplatin, Fluorouracil, and Radiation Therapy in Treating Patients With Stage II or Stage III Esophageal Cancer

A Phase 1/2 study testing cetuximab, fluorouracil and oxaliplatin in people with Esophageal Cancer, run by Technical University of Munich at 3 sites in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

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. Cetuximab may also make tumor cells more sensitive to radiation therapy. 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, fluorouracil and oxaliplatin
Type of treatment
Surgery or procedure
How many people
43 participants
Where
3 sitesGermany
Study dates
Jul 2006to May 2015
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 of the esophagus, meeting the following criteria:
  • Locally advanced disease (T3-T4, N0-N+ [T2, N0 for cervical esophageal carcinoma])
  • Potentially resectable disease
  • No distant metastases (M1b)
  • No tumor infiltration of the tracheobronchial system
  • Bartels preoperative risk analysis < 22

PATIENT CHARACTERISTICS:

  • ECOG performance status (PS) 0-1 or Karnofsky PS 70-100%
  • Creatinine ≤ 1.5 mg/dL OR creatinine clearance > 60 mL/min
  • Bilirubin ≤ 1.5 mg/dL
  • ALT and AST ≤ 2 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2 times ULN
  • WBC ≥ 3,000/mm³
  • Granulocyte count ≥ 2,000/mm³
  • Platelet count ≥ 100,000/mm³
  • No pre-existing polyneuropathy > grade 1
  • No active uncontrolled infection
  • PaO_2 ≥ 60 mm Hg on room air
  • FEV_1 ≥ 60% of normal
  • No New York Heart Association class II-IV cardiac insufficiency
  • Ejection fraction ≥ 35%
  • No angina pectoris (at rest or under stress) unexplained by interventional cardiology
  • No myocardial infarction within the past 6 months
  • No histologically confirmed liver cirrhosis
  • No other malignancy within the past 5 years except carcinoma in situ of the cervix or nonmelanomatous skin cancer
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy
  • No prior radiotherapy to the thorax region
  • No current esophageal stent

Trial locations and contacts

3 sites in 1 country.

Germany3 sites

  • Charite University Hospital - Campus Virchow Klinikum

    Berlin, D-13353

  • Universitaetsklinikum Giessen und Marburg GmbH - Marburg

    Marburg, D-35033

  • Klinikum Rechts Der Isar - Technische Universitaet Muenchen

    Munich, D-81675

Other trials in Germany

About this study

Official title: Neoadjuvant Radiochemotherapy in Local Advanced Squamous Cell Carcinoma of the Esophagus With Weekly Cetuximab Plus Oxaliplatin Plus Continuous IV. 5-FU and Conventional Fractionated External Multi-Field Irradiation up to 45 Gray. A Phase I/II Study

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. Cetuximab may also make tumor cells more sensitive to radiation therapy. Drugs used in chemotherapy, such as oxaliplatin and fluorouracil, 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, chemotherapy, and 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 and best dose of oxaliplatin and fluorouracil when given together with cetuximab and radiation therapy and to see how well they work in treating patients with stage II or stage III esophageal cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the maximum tolerated dose of oxaliplatin and fluorouracil when administered with cetuximab and radiotherapy in patients with stage II or III squamous cell carcinoma of the esophagus. (Phase I)
  • Determine the response rate in patients treated with this regimen. (Phase II)

Secondary

  • Determine the toxicity of this regimen in these patients.
  • Determine the postoperative complication rate and lethality in patients treated with this regimen.
  • Determine the R0 resection rate in patients treated with this regimen.
  • Determine the overall survival of patients treated with this regimen.
  • Determine the event-free survival of patients treated with this regimen.
  • Determine the metabolic response rate in patients treated with this regimen.

OUTLINE: This is a phase I, dose-escalation study of oxaliplatin and fluorouracil followed by an open-label, phase II study.

  • Phase I: Patients receive cetuximab IV over 60-90 minutes on days -15, -8, 1, 8, 15, 22, and 29; oxaliplatin IV over 120 minutes on days 1, 8, 22, and 29; and fluorouracil IV continuously on days 1-5, 8-12, 15-19, 22-26, and 29-33. Patients undergo radiotherapy on days 1-5, 8-12, 15-19, 22-26, and 29-33. Patients then undergo radical esophagectomy 29-42 days after the completion of chemoradiotherapy.

Cohorts of 3-6 patients receive escalating doses of oxaliplatin and fluorouracil until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

  • Phase II: Patients receive oxaliplatin and fluorouracil as in phase I at the MTD determined in phase I. Patients also receive cetuximab and undergo radiotherapy and radical esophagectomy as in phase I.

After completion of study therapy, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study.

Keywords
squamous cell carcinoma of the esophagus, stage IIA esophageal cancer, stage IIB esophageal cancer, stage IIIA esophageal cancer, stage IIIB esophageal cancer, stage IIIC esophageal cancer
Medical subject headings
Esophageal Neoplasms, Esophageal Squamous Cell Carcinoma

What participants receive

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

What is being measured

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

  1. Maximum tolerated dose of oxaliplatin and fluorouracil (Phase I)

  2. Response rate (histological remission) (Phase II)

Secondary outcomes (6)

  1. Toxicity as measured by NCI-CTC criteria

  2. Postoperative complication rate and lethality

  3. R0 resection rate

  4. Overall survival

  5. Event-free survival

  6. Metabolic response rate

Timeline

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

  1. First posted23 Jan 2007 (estimated)
  2. Study startJul 2006
  3. Primary completionMay 2010
  4. Study completionMay 2015 (estimated)

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
Masking
None (open label)
Enrolment
43 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00425425
Sponsor's protocol ID
CDR0000516821
Other IDs
KRDI-TUM-OE7-432-LOR-0033-I, EU-20658, EUDRACT-2006-001097-24
Status last verified
Apr 2014
First submitted
19 Jan 2007
Last updated
1 May 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing cetuximab, fluorouracil and oxaliplatin in people with Esophageal Cancer, run by Technical University of Munich at 3 sites in Germany.

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: status not confirmed, as of the sponsor's last update on 1 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Germany. 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?

Results are not available in the source record.

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?

Maximum tolerated dose of oxaliplatin and fluorouracil (Phase I). The study lists 2 primary outcomes in all. 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 NCT00425425.

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 1 May 2014.

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