Study of Intratumoral Hypoxia Using Pre-operative Administration of Pimonidazole

University Health Network, Toronto

Status: Completed

Conditions: Pancreatic Cancer

Treatments: Drug: Pimonidazole hydrochloride

Study type: Observational

Funder types: Other

Identifiers

NCT01248637

UHN REB 10-0350-C

PIMO-PANC

Details and patient eligibility

About

This study involves the administration of a hypoxia marker, pimonidazole hydrochloride, taken orally approximately 24 hours before surgical resection of a pancreatic tumor in order to identify areas of lower oxygen content on tumor samples.

Full description

Intratumoral hypoxia (low oxygen concentration or pO2) occurs when oxygen consumption exceeds its delivery by the vascular system. Hypoxia is associated with adverse patient outcome in many human cancers and this association is hypothesized to be due to a combination of treatment resistance and aggressive tumor biology.

The study of hypoxia is also important as new cancer drugs are being developed that are specifically active on cancer cells in area of tumors with lower oxygen levels.

his study involves administering the hypoxia probe pimonidazole hydrochloride to patients prior to resection of pancreatic adenocarcinoma to evaluate the extent, molecular context and clinical relevance of hypoxia in clinical pancreatic cancer samples and the subsequently derived primary xenograft tumors.

We propose accrual of patients over a 5-year period to evaluate hypoxia within 100 clinical tumor specimens and corresponding primary xenograft tumours where available. The complementary techniques of wide-field multicolor fluorescence image analysis microscopy and high level flow cytometry will be used to identify potential relationships between intratumoral hypoxia and cell proliferation, differentiation, and the expression of putative cancer stem cell markers.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age > 18
• provisional diagnosis of pancreatic cancer
• scheduled resection at UHN
• consented to ICGC Pancreatic Cancer Genome Project
• surgery planned for >2 days away (drug administration has to be 16-20hrs before surgery)

Exclusion criteria

• not participating in ICGC
• contraindications to pimonidazole (allergy)
• surgery scheduled for same or next day (not enough time to arrange for drug administration)

Trial design

200 participants in 1 patient group

Pimonidazole hydrochloride

Description:

Oral pimonidazole is administered at a dose of 0.5gm/m2 once approximately 24 hrs prior to surgery

Treatment:

Drug: Pimonidazole hydrochloride