Safety and Efficacy Study of Panitumumab+Irinotecan in Patients Wild-Type (WT) KRAS Metastatic Colorectal Cancer Refractory to Irinotecan Based Chemotherapy (SPECTRA)

NCT00958386 | Completed Phase 2

• 1 other identifier: TTD-08-06
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to evaluate the efficacy and safety of the combination of Panitumumab with Irinotecan in patients with Wild-Type KRAS metastatic colorectal cancer refractory to irinotecan based chemotherapy.

Conditions

Metastatic Colorectal Cancer

Keywords

colorectal cancer; Panitumumab; irinotecan

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  2009-2012

Secondary Outcomes (10)

• disease control rate

  2009-2012

• duration of response

  2009-2012

• time to progression

  2009-2012

• time to response

  2009-2012

• time to treatment failure

  2009-2012

Study Arms (1)

1

EXPERIMENTAL

Panitumumab+irinotecan

Drug: Panitumumab+irinotecan

Interventions

Panitumumab+irinotecan DRUG

Panitumumab will be administered as a 60 minute ± 15 minutes IV infusion, just prior to administration of chemotherapy at a dose of 6 mg/kg on day 1 of each cycle. A cycle of Panitumumab is defined as 14 days. Irinotecan chemotherapy (180 mg/m2 in 90 min on day 1 of each cycle) will be administered after the administration of Panitumumab. Each treatment cycle will have a duration of 14 days.

1

Eligibility Criteria

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

You may qualify if:

• Competent to comprehend, sign, and date an IEC-approved informed consent form.
• Men or women 18 years of age or older at the time the written informed consent is obtained.
• Histologically confirmed metastatic adenocarcinoma of the colon or rectum
• Wild-Type KRAS (No mutation) by allelic discrimination on tumor DNA.
• Karnofsky performance status ≥ 70% at the time of enrolment in the study.
• Within seven days prior to initiating study treatment:
• Adequate bone marrow function: neutrophils ≥ 1.5x109/ L; platelets ≥ 100x109/L; hemoglobin ≥ 9g/dL.
• Hepatic functions as follows: total bilirubin count ≤ 1.5 x ULN; ALAT and ASAT ≤ 2.5 x ULN (≤5 x ULN in case of liver metastasis).
• Renal function: serum creatinine ≤1.5 ULN
• Metabolic functions: magnesium ≥ lower limit of normal (LLN), calcium ≥ lower limit of normal (LLN)
• Life expectancy ≥ 3 months.

You may not qualify if:

• Prior malignant tumor in the last 5 years, except a history of basal cell carcinoma of the skin or pre-invasive cervical cancer.
• Documented or suspected central nervous system metastases.
• Significant cardiovascular disease including unstable angina or myocardial infarction within 12 months before initiating study treatment or a history of ventricular arrhythmia.
• Prior anti-EGFr antibody therapy (eg, Cetuximab) or treatment small molecule EGFr tyrosine kinase inhibitors (eg, Erlotinib) or EGFR signal transduction inhibitors. Subjects who discontinue their first dose of anti-EGFR therapy (Cetuximab) because of an infusion reaction may participate in this clinical trial.
• Paraffin-embedded tissue or unstained tumor slides from primary or metastatic tumor not available (blocks available for Translational research).
• History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline chest CT scan.
• Treatment for systemic infection within 14 days before initiating study treatment.
• Acute or sub-acute intestinal occlusion and /or active inflammatory bowel disease or other bowel disease causing chronic diarrhoea (defined as \> 4 loose stools per day).
• History of Gilbert's syndrome or dihydropyrimidine deficiency.
• History of any medical condition that may increase the risks associated with study participation or may interfere with the interpretation of the study results.
• Known positive test for human immunodeficiency virus infection, hepatitis C virus, and chronic active hepatitis B infection.
• Subject allergic to the ingredients of the study medication or to Staphylococcus protein A.
• Any co-morbid disease that would increase risk of toxicity.
• Any kind of disorder that compromises the ability of the subject to give written informed consent and/or comply with the study procedures.
• Any investigational agent within 30 days before initiation of the treatment.

Sponsors & Collaborators

• Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD): lead
• Amgen: collaborator

Study Sites (1)

Spanish Cooperative Group for Gastrointestinal Tumour Therapy

Madrid, 28046, Spain

Location

MeSH Terms

Conditions

Colorectal Neoplasms

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

Study Officials

• Josep Tabernero, MD, phD

  Hospital Vall de Hebrón. Barcelona. Spain

  STUDY CHAIR

• Enrique Aranda, MD; phD

  Hospital Reina Sofía. Cordoba. Madrid

  STUDY CHAIR

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 12, 2009
• First Posted: August 13, 2009
• Study Start: August 1, 2009
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: March 24, 2015

Record last verified: 2015-03

Locations

ES (1)