BrUOG-PA-209: Lapatinib and Gemcitabine for Metastatic Pancreaticobiliary Cancer

Part of paid clinical trials in Providence, Rhode Island.

Sponsor
Brown University
Study ID
NCT00447122
Phase
PHASE1
Status
Terminated

Conditions

  • Metastatic Pancreatic Cancer

Eligibility Criteria

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

Interventions

  • Gemcitabine 1000mg/m2 30 minutes — DRUG
    1000mg/m2 30 minutes
  • Lapatinib 1000mg/d — DRUG
    1000mg/d
  • Lapatinib 1500mg/d — DRUG
    1500mg/d
  • Gemcitabine 1000mg/m2 100minutes — DRUG
    1000mg/m2 100minutes
  • Oxaliplatin 100mg/m2 — DRUG
    100mg/m2

Study Details

Phase I study of lapatinib and gemcitabine for patients with metastatic pancreaticobiliary cancer.

Key Dates

Start date
Mar 31, 2007
Status verified
Jan 2022
Primary completion
Aug 31, 2008
Completion
Aug 31, 2008

Study Design

Enrollment
25 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: treatment 1
    Gemcitabine 1000mg/m2 with lapatinib 1000mg/d weekly x 3 weeks
  • Experimental: treatment 2
    Gemcitabine 1000mg/m2 with lapatinib 1500mg/d weekly X 3 weeks
  • Experimental: treatment 3
    gemcitabine 1000 mg/m2 and oxaliplatin 100 mg/m2 on days 1 and 14 of a 28-day cycle with lapatinib 1000 mg/d
  • Experimental: treatment 4
    gemcitabine 1000 mg/m2 and oxaliplatin 100 mg/m2 on days 1 and 14 of a 28-day cycle with lapatinib 1500 mg/d

Primary Outcome Measure

Overall Survival for Patients With Metastatic Pancreatic Cancer. [ Time Frame: Date of study entry until the date of death, up to 12 months. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Lifespan HospitalsProvidenceRhode Island02903-

Find similar trials in Providence, RI

By research site
Lifespan Hospitals· Providence, RI

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