Nelfinavir, a Phase I/Phase II Rectal Cancer Study

NCT00704600 | Completed Phase 1 DMC

• 1 other identifier: MEC 07-03-026
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Colorectal Cancer; Colorectal Carcinoma; Colorectal Tumors; Neoplasms, Colorectal

Keywords

Locally advanced rectal cancer; nelfinavir; radiosensitivity; chemoradiation

Outcome Measures

Primary Outcomes (1)

• phase I: Incidence of any grade 3 or higher non-hematological or grade 4 or higher hematological toxicity (CTCAE v3.0) and of grade 4 or higher postoperative toxicity within 30 days post-surgery phase II:rate of pathological complete remission

  22 wks

Study Arms (1)

nelfinavir

EXPERIMENTAL

see intervention

Drug: nelfinavir

Interventions

nelfinavir DRUG

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

Also known as: Viracept

nelfinavir

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven adenocarcinoma of the rectum (tumor \<15cm from anal verge)
• Age \>= 18 years
• UICC T3-4 N0-2 M0
• WHO performance status 0-2
• Less than 10 % weight loss the last 6 months
• No recent (\< 3 months) severe cardiac disease (arrhythmia, congestive heart failure, infarction)
• Serum bilirubin = or \< 3x normal
• ASAT and ALAT = or \< 2,5x normal
• Creatinin clearance \>50 ml/min
• Willing and able to comply with the study prescriptions
• No history of prior pelvic radiotherapy
• No known HIV infection
• No hemophilia
• No concurrent medication that is metabolized by the CYP3A4 isoenzyme (calcium channel blockers, antifungal agents, macrolide antibiotics, gastrointestinal prokinetics, terfenadin, midazolam)
• Statins should be stopped (except pravastatin and fluvastatin),

You may not qualify if:

• the opposite of the above

Sponsors & Collaborators

• Maastricht Radiation Oncology: lead

Study Sites (1)

Maastro clinic

Maastricht, 6229 ET, Netherlands

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Nelfinavir

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Ph. Lambin, MD PhD

  Maastro Clinic, The Netherlands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2008
• First Posted: June 25, 2008
• Study Start: September 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: July 1, 2013
• Last Updated: December 8, 2014

Record last verified: 2014-12

Locations

NL (1)