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| Sponsors and Collaborators: |
University Health Network, Toronto Pfizer |
|---|---|
| Information provided by: | University Health Network, Toronto |
| ClinicalTrials.gov Identifier: | NCT00160875 |
Purpose
Cancer of the esophagus is a very serious cancer. Studies have shown that using chemotherapy and radiation before surgery is the most promising treatment approach, with one quarter to one half of tumors shrinking by 50% or more in size after chemotherapy and radiation. In patients who have a very good response to this treatment, survival following esophagectomy has increased, although the amount of increase has varied quite a bit between the different studies. Older studies have used the drugs Cisplatin and 5-fluoruracil. Although this combination of drugs has been beneficial, we wish to use a newer combination of drugs which may be more effective for esophageal cancer. The chemotherapy drugs used in this study are Cisplatin and Irinotecan. We also want to find out what side effects these drugs cause when given with radiation, and how often these side effects occur.
| Condition | Intervention | Phase |
|---|---|---|
|
Esophageal Cancer |
Drug: Irinotecan hydrochloride trihydrate Drug: Cisplatin |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Phase II Study to Assess the Efficacy of Combined Pre-Operative Chemo (CPT11, Cisplatin), Radiotherapy (External Beam, Brachytherapy), Plus Surgery for Potentially Resectable Thoracic Esophageal Cancer |
| Study Start Date: | November 2002 |
Historical surgical series have reported that the chance of cure with surgery alone is approximately one in four. Many phase II studies and some phase III studies have examined the role of induction (preoperative) chemotherapy and radiation. In general, these studies have demonstrated a trend to improved survival using an induction regimen with one phase III study reporting a significant improvement in survival. Two meta-analyses have failed to demonstrate a clear advantage of an induction regimen.
When these trials are reviewed, it is apparent that there is a subgroup of patients who are found at the time of resection to have had a complete pathological response to their treatment, and these patients clearly experience improved survival.
These previous trials have used older chemotherapy agents. Nevertheless, cisplatin remains one of the most active drugs available for treating solid tumours. Irinotecan is a newer drug that has demonstrated significant activity in colorectal cancer and more recently in esophageal cancer. A previous single institution trial of cisplatin and irinotecan in esophageal cancer demonstrated a significant response and acceptable toxicity.
By giving one cycle of chemotherapy alone first, it is expected that the dysphagia usually experienced by these patients will improve sufficiently and that nutritional support, i.e. feeding tube, will not be required (as has been demonstrated in a previous study of this drug combination). The same drugs will then be given concurrently with external beam radiation in order to take advantage of the radiosensitizing properties of both these drugs.
This will be followed by a boost dose of radiation, which will provide a total dose in the tumourcidal range. Surgery will follow the boost dose of radiation.
This study proposes to combine two drugs with demonstrated activity in esophageal cancer, cisplatin and Irinotecan, with radiation prior to surgery, with the hypothesis that these more active agents will offer better control of distant metastatic disease. Their radiosensitizing properties, when combined with radiation, will improve local control and provide an increased rate of pathological complete response in patients with surgically resectable esophageal cancer.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Hematology:
Neutrophils > 1.5 x 109/L Platelets > 100 x 109/L
Hepatic function:
Total bilirubin < 1.25x ULN AST (SGOT) and ALT (SGPT) < 2.5 x ULN Alkaline phosphatase <2.5 x ULN
Renal function:
Serum creatinine < 160 umol/L or creatinine clearance > 60 ml/min (actual or calculated by the Cockcroft-Gault method as follows):
weight (kg) x (140 - age) K x serum creatinine*
for serum creatinine in *mol/L, K=0.814 in man, K=0.96 in woman
Exclusion Criteria:
Contacts and Locations| Canada, Ontario | |
| University Health Network | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Principal Investigator: | Darling E Gail, M.D., FRCSC | University Health Network, Toronto |
| Principal Investigator: | Knox J Jennifer, MD,MSc,FRCPC | University Health Network, Toronto |
| Principal Investigator: | Wong KS Rebecca, MSC, FRCSC | University Health Network, Toronto |
More Information
| Study ID Numbers: | 02-0484-C |
| Study First Received: | September 8, 2005 |
| Last Updated: | November 13, 2006 |
| ClinicalTrials.gov Identifier: | NCT00160875 |
| Health Authority: | Canada: Health Canada |
|
esophageal esophagus irinotecan CPT11 cisplatin |
|
Digestive System Neoplasms Digestive System Diseases Cisplatin Esophageal disorder Gastrointestinal Diseases Head and Neck Neoplasms |
Esophageal Neoplasms Irinotecan Gastrointestinal Neoplasms Esophageal Diseases Esophageal neoplasm Camptothecin |
|
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Radiation-Sensitizing Agents Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Enzyme Inhibitors Antineoplastic Agents, Phytogenic Pharmacologic Actions |
