Esophageal Cancer Clinical Trial
Official title:
Phase II Randomized Trial of Sequentially Administered CPT-11 and Mitomycin C in Patients With Advanced Esophageal and Stomach Cancer
Verified date | December 2017 |
Source | Ohio State University Comprehensive Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To determine the most efficacious of two combination regimens of sequential CPT-11 and MMC in patients with advanced and previously untreated esophageal and GE junction adenocarcinomas.
Status | Completed |
Enrollment | 80 |
Est. completion date | February 2010 |
Est. primary completion date | October 2006 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Must have pathologically confirmed & measurable advanced esophageal or Gastroesophageal junction adenocarcinoma - No prior chemotherapy - Prior radiation allowed if <=20% of bone marrow was irradiated - Target lesions must not be in radiation field. |
Country | Name | City | State |
---|---|---|---|
United States | Ohio State University | Columbus | Ohio |
Lead Sponsor | Collaborator |
---|---|
Ohio State University Comprehensive Cancer Center | Pharmacia and Upjohn |
United States,
Lustberg MB, Bekaii-Saab T, Young D, Otterson G, Burak W, Abbas A, McCracken-Bussa B, Lustberg ME, Villalona-Calero MA. Phase II randomized study of two regimens of sequentially administered mitomycin C and irinotecan in patients with unresectable esophag — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Most efficacious of two combination regimens of sequential CPT-11 and MMC in patients with advanced and previously untreated esophageal and GE junction adenocarcinomas | 2001-2010 | ||
Secondary | Evaluate gene expression profile of NQ01, and Topo I genes in peripheral blood mononuclear cells and tumor tissue during therapy with MMC and CPT-11 | 2001-2010 | ||
Secondary | Evaluate the frequency of NQ01 gene mutations in patients with esophageal and GE junction adenocarcinomas and its association to prognosis and antitumor activity. | 2001-2010 | ||
Secondary | Evaluate if pre- and/or post-treatment Topo I-, CE and NQ01-gene expression in fresh tumor specimens and adjacent tissue, are associated with antitumor efficacy or toxicity. | 2001-2010 |
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