A Phase I Trial of Capecitabine in Combination With Gemcitabine and Erlotinib for Advanced Pancreatic Cancer

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT00480584
Phase
PHASE1
Status
Completed

Conditions

  • Metastatic Pancreatic Carcinoma

Eligibility Criteria

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

Interventions

  • gemcitabine — DRUG
    Levels 1 through 4: 1000 mg/m\^2
  • capecitabine — DRUG
    Level 1: 500 mg/m\^2; Level 2: 825 mg/m\^2; Level 3: 1000 mg/m\^2; Level 4: 1250 mg/m\^2
  • erlotinib — DRUG
    Levels 1 through 4: 100 mg

Study Details

This is a phase I clinical trial examining the safety, feasibility, and toxicity of gemcitabine and erlotinib when given in combination with capecitabine in adult patients with locally advanced unresectable or metastatic pancreatic adenocarcinoma. Treatment will be administered at Moffitt on an outpatient basis and consists gemcitabine once per week for 3 weeks, followed by a week off treatment. Erlotinib (tablet) taken by mouth continuously starting with day one of cycle 1 with capecitabine taken twice per day on days 1-14 of each cycle followed by a 2 week off treatment rest period. An accelerated dose-escalation scheme will be employed with 4 planned dose levels. Whenever patients have been enrolled at a given dose with at most 1 DLT, the protocol will be stopped and the dose will be called the maximum tolerated dose (MTD). Patients will be treated at the recommended phase II dose (RPTD) to confirm tolerability at that dose. In the absence of treatment delays due to adverse events, treatment may continue for 6 cycles or until disease progression and patients may continue on the study regimen unless they experience an adverse event that meets the criteria for a dose limiting toxicity.

Key Dates

First listed
May 31, 2007
Start date
Apr 30, 2007
Status verified
Nov 2012
Primary completion
Nov 30, 2012
Completion
Nov 30, 2012

Study Design

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

Arms

  • Experimental: GemCap-T Dose Escalation
    GemCap-T, capecitabine in combination with gemcitabine. Dose Escalation 6 Cycles @ 28 Days.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) [ Time Frame: Within 4 months of Cycle 1 Day 1 (C1D1) ]

Locations (1)

FacilityCityStateZIPSite coordinators
H. Lee Moffitt Cancer Center & Research InstituteTampaFlorida33612-

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H. Lee Moffitt Cancer Center & Research Institute· Tampa, FL

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