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Weekly Oxaliplatin and Irinotecan in Recurrent or Metastatic Esophageal Carcinoma

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ClinicalTrials.gov Identifier: NCT00256269
Recruitment Status : Completed
First Posted : November 21, 2005
Last Update Posted : August 16, 2011
Information provided by:

Study Description
Brief Summary:
The combination of cisplatin and irinotecan has significant anti-tumor activity in esophageal cancer. Oxaliplatin has been shown to have activity in combination with 5 FU and radiation in treatment of locally advanced esophageal cancer. Oxaliplatin also has better side effects profile than cisplatin and may be able to overcome tumors that have developed cisplatin resistance. The standard treatment of locally advanced esophageal cancer has been cisplatin, 5FU and radiation followed by possible esophagectomy. However, a large portion of these patients will relapse and the tumor may develop resistance to cisplatin and/or the cumulative toxicity from previous treatment forbids the use of cisplatin again. Weekly combination of oxaliplatin and irinotecan has been shown to be active and well tolerated in elderly population with refractory colorectal cancer. Therefore, we propose this phase II trial of a weekly oxaliplatin and irinotecan to test the effectiveness and the tolerability of this regimen in metastatic and/or recurrent esophageal cancer.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Gastroesophageal Cancer Drug: Oxaliplatin Drug: Irinotecan Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Weekly Oxaliplatin and Irinotecan in the Treatment of Recurrent or Metastatic Esophageal Carcinoma
Study Start Date : June 2005
Primary Completion Date : February 2008
Study Completion Date : April 2011

Arms and Interventions

Intervention Details:
    Drug: Oxaliplatin
    40 mg/m2 IV over 60 minutes Every 21 days
    Drug: Irinotecan
    60 mg/m2 IV over 60 minutes, immediately following oxaliplatin Every 21 days

Outcome Measures

Primary Outcome Measures :
  1. To assess the overall response rate [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. To assess the frequency and severity of toxicities [ Time Frame: 5 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All patients must have histologically or cytologically confirmed diagnosis of squamous cell carcinoma or adenocarcinoma of the esophagus. Patients with tumors of the gastroesophageal junction were eligible if at least 50% of the tumor involved the esophagus.
  • Patients must have locally advanced (i.e. unresectable) or metastatic disease
  • All sites of disease must be assessed and designated as measurable or non-measurable disease as documented by CT, MRI, X-ray physical Each of the criteria in the following section must be met in order for a patient to be eligible for registration.
  • Patients must not have received prior chemotherapy for chemotherapy for advanced or metastatic esophageal cancer. Chemotherapy given adjuvantly or as a radiosensitizer is allowed if more than 8 weeks have elapsed since the treatment was completed and they have recovered from any treatment related toxicity.
  • Patients may have received prior radiotherapy if there has been complete recovery from all radiation-induced toxicities. At least 4 weeks must have been elapsed from the completion of radiation therapy to the time of registration. If lesions within the radiation port are to be used to assess response to therapy, those lesions must have demonstrated clear progression by the criteria outlined in Section 10.2d following completion of radiation therapy.
  • Patients must not have a surgical procedure for esophageal cancer within 4 weeks prior to registration. Patients must have completely recovered from all surgery prior to registration.
  • All patients must be 18 years of age or older
  • Patients must have a Zubrod performance of 0-2
  • Patients with any evidence of active or uncontrolled infection, recent myocardial infection, unstable angina, or life-threatening arrhythmia are not eligible.
  • Patients with severe psychiatric disorder are not eligible.
  • Patients with known brain metastasis are not eligible. However, brain-imaging studies are not required for eligibility if the patient has no neurological signs or symptoms. If brain-imaging studies are performed, they must be negative for disease.
  • No other prior malignancy is allowed except for adequately treated basal cell or squamous cell carcinoma, in situ cervical cancer, or adequately treated Stage I and II cancer from which the patient is in complete remission, or any other malignancy from which the patient has been disease-free for 5 years.
  • Patients should not have active infection.
  • Patients should not have psychological, familial, sociological, or geographical conditions that do not permit medical follow-up and compliance with study protocol.
  • Except for cancer-related abnormalities, patients should not have unstable or pre-existing major medical conditions.
  • Patients should not have any immediate life-threatening complications of their malignancies.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00256269

United States, California
Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Principal Investigator: Sai-Hong Ignatius Ou, MD Chao Family Comprehensive Cancer Center
More Information

Responsible Party: Sai-Hong Ignatius Ou, MD, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00256269     History of Changes
Other Study ID Numbers: UCI 04-09
2004-3849 ( Other Identifier: University of California, Irvine )
First Posted: November 21, 2005    Key Record Dates
Last Update Posted: August 16, 2011
Last Verified: August 2011

Keywords provided by University of California, Irvine:
Esophageal Cancer
Gastroesophageal junction cancer

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action