Oxaliplatin and Irinotecan in Recurrent or Metastatic Esophageal and Gastroesophageal (GE) Junction Carcinoma
|ClinicalTrials.gov Identifier: NCT00256269|
Recruitment Status : Terminated (Study was terminated by funding entity)
First Posted : November 21, 2005
Last Update Posted : January 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Cancer Gastroesophageal Cancer||Drug: Oxaliplatin Drug: Irinotecan||Phase 2|
Esophageal cancer represents the seventh cause of cancer death in American men, and more than 90% of patients diagnosed with esophageal cancer will ultimately die of their disease. In the United States, 13,900 new cases of esophageal cancer and 13,000 deaths from esophageal cancer are anticipated in 2003 (Jemal et al, 2003). The lifetime risk of esophageal cancer is 0.8% for men and 0.3% for women (Ries et al, 2002). The risk increases with age, with a mean age at diagnosis of 67 years (Ries et al, 2002; Daly et al, 2000). Adenocarcinoma of the esophagus or gastroesophageal junction, a previously rare disease, is rapidly increasing in incidence in the United States and western countries and now accounts for more than half of newly diagnosed disease (Devesa et al, 1998).
Half of patients diagnosed with esophageal cancer present with overt metastatic disease, and chemotherapy is the mainstay of palliation in this setting. In patients who present initially with locoregional disease, the majority will eventually develop metastatic disease as well, with or without local recurrence of disease. Metastatic esophageal carcinoma is an incurable disease with median survival duration of 4 to 8 months. Combination chemotherapy, most often cisplatin-based, results in partial responses in 25% to 50% of patients with metastatic disease and rare complete responses, including a 35% response rate reported for the commonly used combination of cisplatin and fluorouracil (Ilson et al, 1996). Recent chemotherapy trials indicate an overlap in response rates for metastatic adenocarcinoma and squamous carcinoma carcinoma of the esophagus (Ilson et al, 1997). Responses to chemotherapy are generally short-lived, and toxicity of cisplatin-based chemotherapy, particularly in the palliation of metastatic disease, is often substantial and underscores the need to identify new agents in the treatment of esophageal carcinoma.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Weekly Oxaliplatin and Irinotecan in the Treatment of Recurrent or Metastatic Esophageal Carcinoma and Carcinoma of the Gastroesophageal (GE) Junction|
|Actual Study Start Date :||June 2005|
|Primary Completion Date :||February 7, 2007|
|Study Completion Date :||February 7, 2007|
Experimental: Oxaliplatin plus Irinotecan
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.
40 mg/m2 IV over 60 minutes Every 21 daysDrug: Irinotecan
60 mg/m2 IV over 60 minutes, immediately following oxaliplatin Every 21 days
- To assess the overall response rate [ Time Frame: 5 years ]To assess the overall response rate (complete and partial response) to a weekly combination of oxaliplatin and irinotecan in patients with unresectable or metastatic esophageal cancer or cancer of the gastro-esophageal (GE) junction.
- Number of participants with treatment-related adverse events as assessed by CTCAE v3.0 [ Time Frame: 5 years ]To assess the frequency and severity of toxicities associated with this treatment
- Progression Free Survival [ Time Frame: 5 years ]from date of registration to date of first observation of progressive disease (as outlined in 10.2d), death due to any cause or symptomatic deterioration.
- Evaluation of Time to Death [ Time Frame: 5 years ]Analysis timeline would be from the date of registration to date of death due to any cause.
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|
|Principal Investigator:||Sai-Hong Ignatius Ou, MD||Chao Family Comprehensive Cancer Center|