Cisplatin, Capecitabine, and Radiation Therapy With or Without Cetuximab in Treating Patients With Esophageal Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Cancer Research UK
Information provided by (Responsible Party):
Wales Cancer Trials Unit
ClinicalTrials.gov Identifier:
NCT00509561
First received: July 30, 2007
Last updated: December 17, 2012
Last verified: December 2012
  Purpose

RATIONALE: Drugs used in chemotherapy, such as cisplatin and capecitabine, work in different ways to kill tumor cells or stop them from growing. Radiation therapy uses high-energy x-rays to kill tumor cells. 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 stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving cisplatin together with capecitabine and radiation therapy is more effective with or without cetuximab in treating esophageal cancer.

PURPOSE: This randomized phase II/III trial is studying the side effects and how well giving cisplatin together with capecitabine, radiation therapy, and cetuximab works compared with giving cisplatin, capecitabine, and radiation therapy without cetuximab in treating patients with esophageal cancer.


Condition Intervention Phase
Esophageal Cancer
Biological: cetuximab
Drug: capecitabine
Drug: cisplatin
Radiation: radiation therapy
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomised Phase II/III Multi-Centre Clinical Trial of Definitive Chemotherapy, With or Without Cetuximab, in Carcinoma of the Oesophagus

Resource links provided by NLM:


Further study details as provided by Wales Cancer Trials Unit:

Primary Outcome Measures:
  • Treatment-failure rate at 24 weeks [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Feasibility [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Quality of life [ Designated as safety issue: No ]
  • Quality of assurance [ Designated as safety issue: No ]
  • Health economics [ Designated as safety issue: No ]

Enrollment: 259
Study Start Date: February 2008
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Chemo-radiotherapy Drug: capecitabine Drug: cisplatin Radiation: radiation therapy
Experimental: Chemo-radiotherapy plus cetuximab Biological: cetuximab Drug: capecitabine Drug: cisplatin Radiation: radiation therapy

Detailed Description:

OBJECTIVES:

Primary

  • To determine whether the addition of cetuximab to definitive chemoradiotherapy comprising cisplatin, capecitabine, and radiotherapy shows evidence of enhanced overall survival in patients with carcinoma of the esophagus.
  • To determine the safety of this regimen in these patients.
  • To determine the feasibility of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive cisplatin IV over 2 hours on days 1, 22, 43, and 64 and oral capecitabine twice daily on days 1-84. Beginning in week 7 patients also undergo radiotherapy 5 days a week for 5 weeks (weeks 7-11). Treatment continues in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive cisplatin and capecitabine and undergo radiotherapy as in arm I. Patients also receive cetuximab IV over 1-2 hours on day 1 in weeks 1-12. Treatment continues in the absence of disease progression or unacceptable toxicity.

Quality of life and health economics are assessed at baseline, during treatment, and at pre-specified time points during follow-up.

After completion of study treatment, patients are followed every 3 months for 1 year, every 4 months for 1 year, and then annually for a minimum of 5 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed carcinoma of the esophagus

    • Adenocarcinoma
    • Squamous cell
    • Undifferentiated carcinoma
    • Siewert type I tumor of the gastroesophageal junction
  • Localized, nonmetastatic disease (T1-4, N0-1) confirmed by endoscopic ultrasound (EUS) and spiral CT scan
  • Total disease length (primary and lymph nodes) < 10 cm by EUS
  • Not suitable for surgery (either for medical reasons or patient's choice)
  • No metastatic disease (i.e., M1a or M1b according to UICC TNM version 6)
  • No significant (> 2 cm) extension of tumor into the stomach

PATIENT CHARACTERISTICS:

  • WHO performance status 0-1
  • Absolute neutrophil count ≥ 1,500/mm³
  • White blood cell count ≥ 2,000/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 10 g/dL (should be corrected to > 10 g/dL before treatment)
  • Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • ALT/AST ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 3 times ULN
  • Glomerular filtration rate > 40 mL/min OR > 60 mL/min estimated by Cockcroft-Gault formula
  • Adequate cardiac ejection fraction ≥ 40% by MUGA or ECHO
  • FEV_1 ≥ 1 L by spirometry
  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No malignancy within the past 5 years
  • No unstable angina, uncontrolled hypertension, cardiac failure, or other clinically significant cardiac disease
  • No major trauma within the past 4 weeks
  • No known dihydropyrimidine dehydrogenase deficiency
  • No hearing impairment or sensory-motor neuropathy > grade 2

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 4 weeks since prior sorivudine and analogues
  • At least 4 weeks since prior major surgery
  • At least 4 weeks since prior monoclonal antibody
  • At least 3 months since prior radiotherapy
  • No prior treatment for invasive esophageal carcinoma or gastroesophageal junction carcinoma (not including photodynamic therapy or laser therapy for high-grade dysplasia/carcinoma in situ)
  • No other prior treatment for this malignancy that would compromise the ability to deliver definitive mediastinal chemoradiotherapy or compromise survival
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00509561

  Show 55 Study Locations
Sponsors and Collaborators
Wales Cancer Trials Unit
Cancer Research UK
Investigators
Study Chair: Tom Crosby, MD Velindre NHS Trust
  More Information

Additional Information:
No publications provided

Responsible Party: Wales Cancer Trials Unit
ClinicalTrials.gov Identifier: NCT00509561     History of Changes
Other Study ID Numbers: CDR0000558804, WCTU-SCOPE-1, EU-20739, EUDRACT-2006-002241-37, ISRCTN47718479, CTA-17853/0202/001-0001
Study First Received: July 30, 2007
Last Updated: December 17, 2012
Health Authority: Medicines and Healthcare Products Regulatory Agency, United Kingdom:

Keywords provided by Wales Cancer Trials Unit:
adenocarcinoma of the esophagus
squamous cell carcinoma of the esophagus
stage IA esophageal cancer
stage IB esophageal cancer
stage IIA esophageal cancer
stage IIB esophageal cancer
stage IIIA esophageal cancer
stage IIIB esophageal cancer
stage IIIC esophageal cancer

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Capecitabine
Cetuximab
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2014