Neoadjuvant Radiochemotherapy Combined With Panitumumab in Locally Advanced KRAS Wild-type Rectal Cancer

NCT01443377 | Completed Phase 2 DMC

• 1 other identifier: NCT-0001021
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief Summary

This study aims to investigate the combination of panitumumab and a 5-FU-based RCTX in patients with locally advanced KRAS wild-type rectal cancer.

Conditions

Rectal Cancer

Keywords

Neorec; rectal cancer; KRAS; Panitumumab; neoadjuvant; Radiochemotherapy; antibody; locally advanced KRAS wild type rectal cancer

Outcome Measures

Primary Outcomes (1)

• Histopathological complete response rate (pCR)

  pCR determined by means of the resection specimens

  at week 14 after tumor resection

Secondary Outcomes (7)

• Objective tumor response rate assessed by MRI of the pelvis (incl. RECIST)

  at day 14 and week 12

• Metabolic tumor response rate assessed by means of changes in the standardized uptake values (SUV) using FDG-PET-CT (incl. RECIST)

  day 14 and at week 14 before surgery

• Pathological tumor regression grades will be classified according to Becker

  at week 14 after surgery

• Quality of Life (QoL) will be assessed using the EORTC QLQ-C30 in combination with the colorectal cancer-specific quality of life questionaire module (QLQ-CR29)

  between day 0 and week 18 end of study

• distant metastases-free survival

  during follow up every 6 months until death or until 2 years after LPO

Interventions

Panitumumab BIOLOGICAL

Intravenous (IV), Panitumumab 6 mg/kg BW q2w d1-d57 (5 times total); begin on day 1 (run-in-phase) and subsequent application on days 15, 29 43 and 57.

Also known as: Vectibix®

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed, potentially resectable rectal adenocarcinoma staged as uT3/4 N0/1 by endosonography or cT3/4 by MRI of the pelvis with or without local lymph node metastases.
• Wild-type KRAS.
• ECOG-performance status 0 or 1.
• Age ≥ 18 years.
• Laboratory requirements:
• Haematology: Leucocyte count \> 3,000/mm³, neutrophil count ≥1.5x109/L, hemoglobin ≥ 8 g/dL, platelet count ≥100x109/L.
• Hepatic Function: Total bilirubin ≤ 1.5 time the upper normal limit (UNL), ASAT ≤ 2.5xUNL in absence of liver metastases or ≤ 5xUNL in presence of liver metastases, ALAT ≤ 2.5xUNL in absence of liver metastases or ≤ 5xUNL in presence of liver metastases
• Renal Function: Creatinine clearance ≥50 mL/min or serum creatinine ≤1.5xUNL
• Metabolic Function: Magnesium ≥ lower limit of normal, Calcium ≥ lower limit of normal.
• Negative ß-HCG-serum pregnancy test (females of child bearing potential).
• Willing to use double-barrier contraception during study and for 6 months after the end of treatment.
• Ability of patient to understand character and individual consequences of clinical trial
• Written informed consent (must be available before enrollment in the trial)

You may not qualify if:

• Prior EGFR targeting or prior chemo- or radiotherapy or tumor surgery.
• Evidence of any distant metastases.
• Manifest or previous secondary malignancies within the last 5 years.
• Uncontrolled infection.
• Clinically significant cardiovascular disease NYHA classification III or IV (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrollment/randomization.
• History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on screening chest CT scan.
• Diabetes mellitus
• Subject pregnant or breast feeding, or planning to become pregnant within 6 month after the end of treatment.
• Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment.
• Active serious illness which renders the patient unsuitable for study entrance, multiple blood sampling or the above mentioned biopsies.
• History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product.
• Participation in other clinical trials or observation period of competing trials, respectively.

Sponsors & Collaborators

• National Center for Tumor Diseases, Heidelberg: lead

Study Sites (2)

National Center for Tumor Disease (NCT)

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Krankenhaus Nord West, Radioonkologische Klinik

Frankfurt am Main, Hesse, 60488, Germany

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Panitumumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Dirk Jaeger, Prof. Dr

  National Center of Tumor Disease, Heidelberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2011
• First Posted: September 29, 2011
• Study Start: July 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2013
• Last Updated: May 7, 2015

Record last verified: 2012-04

Locations

DE (2)