NCT00704600

Nelfinavir, a Phase I/Phase II Rectal Cancer Study

A Phase I/II Trial Testing Nelfinavir, an Inhibitor of Akt Signaling, in Combination With Preoperative Chemoradiotherapy in Patients With Locally Advanced Rectal Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Maastricht Radiation Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim is to study safety and activity of nelfinavir , added to standard chemoradiotherapy in patients with locally advanced rectal cancer. Furthermore analysis of the effect of nelfinavir combined with chemoradiation on tumour tissue will be studied

Detailed description

Objective of the study: The aim is to study safety and activity of nelfinavir, added to standard chemoradiotherapy (28x1.8 Gy and capecitabine 825 mg/m2 BID) in patients with locally advanced rectal cancer. Furthermore analysis of the effect of nelfinavir combined with chemoradiation on tumor tissue will be studied. Study design: This is an open label, single-center phase I/II trial. During phase I the toxicity of 2 dose levels will be studied (750 mg BID and 1250 mg BID). During phase II the activity of nelfinavir in combination with capecitabine and radiotherapy will be studied, using the MTD from phase I. With respect to translational research, phosphorylation of Akt in monocytes and tumorcells will be measured at different timepoints during treatment. Furthermore, dynamic CT-PET scans will be obtained at different time points to get an impression of changes in SUV and perfusion during treatment and to correlate these changes with pathological response. Study population: Patients with locally advanced rectal cancer, who are candidates for chemoradiotherapy. In phase I, 6 patients will be included. In case of the occurrence of dose limiting toxicity, extra patients will be included, according to the rules described in the protocol. In phase II, 55 patients will be included.

Conditions

• Colorectal Cancer
• Colorectal Carcinoma
• Colorectal Tumors
• Neoplasms, Colorectal

Interventions

Type	Name	Description
DRUG	nelfinavir	Phase I: * take nelfinavir tablets (minimum 6, maximum 10) starting 7 days before start of chemoradiotherapy, for 45 days * day 0 and day 7 and week 2-3-4-5-6-7 weekly blood sample * day 0: PET-CT Phase II: * take nelfinavir tablets (MTD from phase 1) starting 7 days before start of chemoradiotherapy, for 45 days * day 0 and day 7 and week 2-3-4-5-6-7 weekly blood sample * day 7 biopsy * day 7, 21 and week 15 :PET-CT + perfusion CT

Timeline

• Start date: 2008-09-01
• Primary completion: 2010-09-01
• Completion: 2013-07-01
• First posted: 2008-06-25
• Last updated: 2014-12-08

Locations

1 site across 1 country: Netherlands