A Clinical Trial of COX and EGFR Inhibition in Familial Polyposis Patients

Conditions

• Adenomatous Polyposis Coli

Eligibility Criteria

Sex

ALL

Age

18 Years - 69 Years

Healthy Volunteers

Not accepted

Interventions

• Erlotinib — DRUG
  Tarceva oral tablets are conventional, immediate-release tablets containing erlotinib as the hydrochloride salt. Erlotinib(75mg)will be taken once daily for six months in combination with sulindac.
• Sulindac — DRUG
  Sulindac is a non-steroidal, anti-inflammatory indene derivative designed for the treatment of arthritic conditions. For this study, sulindac (150mg) will be taken twice daily in combination with erlotinib
• Placebo A — DRUG
  Erlotinib (Tarceva) will provide a 25 mg identical placebo. This will be provided by the Division of Cancer Prevention at the NIH who will receive the drug and placebo from the manufacturer, OSI/Genentech. Dosage for Placebo A will be 75 mg a day for 6 months.
• Placebo B — DRUG
  Sulindac will be encapsulated in 150 mg doses along with an identical encapsulated Placebo B. One 150 mg capsules of Placebo B will be taken twice per day with meals (breakfast and supper).

Study Details

The purpose of this study is to determine in a randomized, placebo-controlled, phase II trial if the combination of sulindac and erlotinib causes a significant regression of duodenal and colorectal adenomas in familial adenomatous polyposis (FAP) and attenuated FAP (AFAP) patients.

Key Dates

First listed

Aug 24, 2010

Start date

Apr 30, 2010

Status verified

May 2016

Primary completion

Jun 30, 2014

Completion

Jul 31, 2014

Study Design

Enrollment

92 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Active Comparator: Erlotinib and Sulindac
  Erlotinib 75 mg per day in combination with sulindac 150 mg twice daily for 6 months.
• Placebo Comparator: Placebo A and Placebo B
  Placebo capsules matching erlotinib active comparator (Placebo A) once daily and placebo capsules matching sulindac active comparator (Placebo B) twice daily for 6 months

Primary Outcome Measure

Change in Duodenal Polyp Burden From Baseline to 6 Months [ Time Frame: Baseline and 6 months ]

Locations (1)

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