A Clinical Trial of Panitumumab in Combination With FOLFIRI Chemotherapy as Second Line Treatment in Subjects With Metastatic Colorectal Cancer Expressing Wild-type KRAS and Who Had Progressed ≥ 6 Months After the Last Dose of the First Line Chemotherapy

NCT01144195 | Unknown Phase 2

• 2 other identifiers: ACROSS-08-012009-010975-26
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

First line chemotherapy treatment regimens for metastatic colorectal cancer (mCRC) present disease-free survival of more than 10 months, and as much as 12 and 15 months for many patients. It is evident that there are 2 groups of patients with metastatic colorectal cancer(mCRC): those who progress during first line treatment or in the 6 months following the last chemotherapy infusion and those who progress after this first 6-month period. There are currently no studies evaluating the efficacy of second line chemotherapy regimens according to the duration of response to first line treatment. It seems logical that patients with less aggressive tumours will benefit more from treatments targeting specific proteins, such as panitumumab, due to the shorter duration of these tumours cell cycle, which makes them less sensitive to chemotherapy. This study is therefore justified to determine an increase in activity and control of the disease in patients who progressed after 6 months of the last first line chemotherapy infusion for metastatic colorectal cancer(mCRC) in subjects expressing wild-type KRAS.

Conditions

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  3 years

Secondary Outcomes (8)

• disease control rate

  3 years

• duration of response

  3 years

• time to response

  3 years

• progression-free survival

  3 years

• time to progression

  3 years

Interventions

Panitumumab + FOLFIRI DRUG

Panitumumab will be administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks. FOLFIRI chemotherapy will be administered once every 2 weeks after the administration of Panitumumab.

Eligibility Criteria

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

You may qualify if:

• Men or women 18 years of age or older
• Competent to comprehend, sign, and date an Independent Ethics Committee (IEC)/Institutional Review Board (IRB)-approved informed consent form
• Adenocarcinoma of the colon or rectum confirmed histologically or cytologically by the investigator in subjects presenting metastatic disease
• Subjects with wild-type KRAS tumor status confirmed by central laboratory assessment of paraffin-embedded tumor tissue from the primary tumor or metastasis.
• Radiologically documented progression of the disease according to modified RECIST criteria, 6 months or more after the last dose of chemotherapy for mCRC.
• Only one previous chemotherapy regimen for mCRC, consisting of first line chemotherapy based on fluoropyrimidines and oxaliplatin (prior adjuvant chemotherapy based on fluoropyrimidine is permitted).
• At least 1 uni-dimensionally measurable lesion of at least 20 mm per modified RECIST criteria. (All sites of disease must be evaluated ≤ 28 days prior to enrollment)
• If subject has prior history of cancer other than colorectal carcinoma, basal cell carcinoma, or cervical carcinoma in situ, then subject must not have had treatment or active disease within 5 years.
• Karnofsky performance status ≥ 70% at the time of enrolment in the study.
• Life expectancy ≥ 3 months
• Prior radiotherapy is acceptable (target lesions should not have been irradiated). At least 14 days must have passed since the administration of the radiotherapy and all signs of early toxicity must have remitted.
• Haematological function (within the 7 days prior to starting the study treatment)::
• Absolute Neutrophil Count(ANC) ≥ 1.5 x 109 cells/L
• Hemoglobin ≥ 9.0 g/dL
• Platelet count ≥ 100 x 109/L

You may not qualify if:

• More than one previous chemotherapy regimen for mCRC consisting of first line chemotherapy based on fluoropyrimidines and/or oxaliplatin (patients receiving first-line chemotherapy based on irinotecan are not candidate for this study).
• Progression of the disease during the first line treatment or less than 6 months after completing the last cycle of first line chemotherapy for mCRC.
• Significant cardiovascular disease, including unstable angina pectoris or myocardial infarction within the 6 months prior to the start of the study treatment, or history of ventricular arrhythmia.
• Previous treatment with anti-EGFr antibodies (e.g. cetuximab) or treatment with small molecule Epidermal Growth Factor Receptor (EGFr) tyrosine kinase inhibitors (e.g. erlotinib).
• History of interstitial pneumonia or pulmonary fibrosis or signs of interstitial pneumonia or pulmonary fibrosis on the baseline chest X-ray.
• Treatment for systemic infection within the 14 days prior to starting the study treatment.
• Active inflammatory bowel or other intestinal disease causing chronic diarrhoea (defined as \> 4 loose bowel movements per day).
• History of Gilbert's syndrome or dihydropyrimidine deficiency.
• History of any disease which could increase the risks associated to participation in the study or interfere in the interpretation of the study results.
• Known positive test for infection by human immune deficiency virus, hepatitis C, chronic active hepatitis B.
• Subject allergic to the ingredients of the study medication of protein A of Staphylococcus.
• Any comorbid disease which could increase the risk of toxicity.
• The subject presents a disorder of any kind which compromises his/her ability to provide informed consent in writing and/or follow the study procedures.
• Major surgery within the 28 days prior to study enrollment.
• Pregnant or breastfeeding women.

Sponsors & Collaborators

• Associacio catalana per a la recerca oncologica i les seves implicacions sanitaries i socials: lead
• Amgen: collaborator

Study Sites (1)

Associació Catalana per la Recerca Oncològica i les Seves Implicacions Sanitaries i Socials

Barcelona, Barcelona, 08021, Spain

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Panitumumab

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)

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

Study Officials

• Carles Pericay, MD PhD

  Corporació Sanitaria Parc Taulí, Sabadell (Spain)

  STUDY CHAIR

• Ferran Losa, Dr.

  Hospital General de l'Hospitalet

  PRINCIPAL INVESTIGATOR

• Pilar Vicente, Dra.

  Hospital General de Granollers

  PRINCIPAL INVESTIGATOR

• Hermini Manzano, Dr.

  Hospital Son Dureta

  PRINCIPAL INVESTIGATOR

• Juan Manuel Campos, Dr.

  Hospital Arnau de Vilanova (Valencia)

  PRINCIPAL INVESTIGATOR

• Joan Manel Gasent, Dr.

  Hospital de Denia

  PRINCIPAL INVESTIGATOR

• Enrique Barrajón, Dr.

  Clínica de Benidorm

  PRINCIPAL INVESTIGATOR

• Inma Guasch, Dra.

  Hospital General de Manresa

  PRINCIPAL INVESTIGATOR

• Antonia Salud, Dra.

  Hospital Arnau de Vilanova (Lleida)

  PRINCIPAL INVESTIGATOR

• Miquel Nogué, Dr.

  Hospital General de Vic

  PRINCIPAL INVESTIGATOR

• Inés Cabezas, Dra.

  Hospital Sant Joan de Reus

  PRINCIPAL INVESTIGATOR

• Jordi Alfaro, MD

  Consorci Sanitari de Terrassa

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 7, 2010
• First Posted: June 15, 2010
• Study Start: September 1, 2009
• Primary Completion: December 1, 2011
• Last Updated: November 10, 2010

Record last verified: 2010-11

Locations

ES (1)