Weekly Oxaliplatin and Irinotecan in Recurrent or Metastatic Esophageal Carcinoma

This study has been completed.
Sponsor:
Information provided by:
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00256269
First received: November 17, 2005
Last updated: August 15, 2011
Last verified: August 2011
  Purpose

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 Intervention Phase
Esophageal Cancer
Gastroesophageal Cancer
Drug: Oxaliplatin
Drug: Irinotecan
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • To assess the overall response rate [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the frequency and severity of toxicities [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Enrollment: 4
Study Start Date: June 2005
Study Completion Date: April 2011
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
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
  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00256269

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

No publications provided

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
Study First Received: November 17, 2005
Last Updated: August 15, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Carcinoma
Esophageal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Oxaliplatin
Irinotecan
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 16, 2014