Chemotherapy & Erlotinib in Treating Patients w/ Esophageal or Gastroesophageal Cancer That Cannot Be Removed by Surgery

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT00539617
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Erlotinib — DRUG
    Tarceva single agent therapy: 150 mg/day PO
  • 5-fluorouracil — DRUG
    5-FU bolus: 400 mg/m2 IV once every 2 weeks for 16 weeks 5-FU infusion: 2400 mg/m2 IV over 46-48 hours, once every 2 weeks for 16 weeks
  • Leucovorin — DRUG
    400 mg/m2 IV once every 2 weeks for 16 weeks
  • Oxaliplatin — DRUG
    85 mg/m2 IV once every 2 weeks for 16 weeks

Study Details

The purpose of this study is to test the safety and effectiveness of erlotinib and FOLFOX in patients with esophageal or gastro-esophageal cancer that cannot be removed by surgery.

Key Dates

First listed
Oct 4, 2007
Start date
Oct 5, 2007
Status verified
Mar 2020
Primary completion
May 12, 2011
Completion
May 12, 2011

Study Design

Enrollment
7 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tarceva and FOLFOX
    COMBINATION THERAPY PHASE: Patients receive erlotinib hydrochloride orally (PO) once daily (QD) on days 1-56. Patients also receive FOLFOX6 therapy comprising oxaliplatin intravenously (IV) over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46-48 hours on days 1, 15, 29, and 43. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity. Patients with stable disease or no evidence of disease after course 2 or subsequent courses continue on to maintenance phase. MAINTENANCE PHASE: Patients receive erlotinib hydrochloride PO QD on days 1-42. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: Up to 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94115-

Find similar trials in San Francisco, CA

By condition
Esophageal cancer
By specialty
OncologyGI oncology
By research site
University of California, San Francisco· San Francisco, CA

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