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Sponsored by: |
Maastricht Radiation Oncology |
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Information provided by: | Maastricht Radiation Oncology |
ClinicalTrials.gov Identifier: | NCT00704600 |
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
Condition | Intervention | Phase |
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Colorectal Cancer Colorectal Carcinoma Colorectal Tumors Neoplasms, Colorectal |
Drug: nelfinavir |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I/II Trial Testing Nelfinavir, an Inhibitor of Akt Signaling, in Combination With Preoperative Chemoradiotherapy in Patients With Locally Advanced Rectal Cancer |
Estimated Enrollment: | 55 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | September 2012 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: nelfinavir
Phase I:
Phase II:
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: J. Buijsen, MD | +31(0)884455666 | jeroen.buijsen@maastro.nl |
Contact: G. Lammering, MD, PhD | +31(0)884455666 | guido.lammering@maastro.nl |
Netherlands | |
Maastro clinic | Recruiting |
Maastricht, Netherlands, 6229 ET | |
Contact: Jeroen Buijsen, MD +31 (0) 884455666 jeroen.buijsen@maastro.nl | |
Contact: Guido Lammering, MD, PhD +31 (0) 884455666 guido.lammering@maastro.nl | |
Sub-Investigator: J. Buijsen, MD | |
Principal Investigator: Philippe Lambin, MD, PhD | |
Sub-Investigator: Guido Lammering, MD, PhD |
Principal Investigator: | Ph. Lambin, MD PhD | MAASTRO Clinic |
Responsible Party: | Maastro clinic ( P. Lambin MD PhD ) |
Study ID Numbers: | MEC 07-03-026 |
Study First Received: | June 23, 2008 |
Last Updated: | September 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00704600 History of Changes |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Locally advanced rectal cancer nelfinavir radiosensitivity chemoradiation |
HIV Protease Inhibitors Anti-HIV Agents Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Colonic Diseases Rectal Neoplasm Intestinal Diseases Antiviral Agents Rectal Diseases |
Intestinal Neoplasms Protease Inhibitors Carcinoma Digestive System Diseases Rectal Cancer Anti-Retroviral Agents Gastrointestinal Neoplasms Nelfinavir Colorectal Neoplasms Neoplasms, Glandular and Epithelial |
Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Rectal Neoplasms Colonic Diseases Rectal Diseases Neoplasms by Site Anti-Retroviral Agents Therapeutic Uses Nelfinavir HIV Protease Inhibitors Digestive System Neoplasms Neoplasms by Histologic Type |
Anti-HIV Agents Enzyme Inhibitors Intestinal Diseases Antiviral Agents Intestinal Neoplasms Pharmacologic Actions Carcinoma Protease Inhibitors Neoplasms Digestive System Diseases Gastrointestinal Neoplasms Colorectal Neoplasms Neoplasms, Glandular and Epithelial |