Study of Panitumumab-Capecitabine-Oxaliplatin In Wild-Type K-Ras Metastatic Colorectal Cancer Patients

NCT01215539 | Completed Phase 2

• 2 other identifiers: HE 6A/092009-012655-26
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 12

Brief Summary

The purpose of this study is to determine whether panitumumab in combination with capecitabine/oxaliplatin are effective as first-line treatment in wild-type k-ras, metastatic colorectal cancer patients.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response

  Response will be evaluated using the RECIST criteria. Response rates will be presented as counts and proportions along with 95% exact confidence intervals. An Objective Response is defined as either a Complete Response or a Partial Response. Analysis will be performed in the intent-to-treat population, i.e. all eligible patients enrolled in the study.

  Tumor response will be assessed every 6 weeks through week 18 and every 3 months thereafter, until disease progression.

Secondary Outcomes (4)

• Overall Survival (OS)

  24 months

• Progression-Free Survival(PFS)

  Tumor response will be assessed every 6 weeks through week 18 and every 3 months thereafter, until disease progression.

• Adverse Events (AE)of all participants will be recorded and assessed upon signature of the informed consent form, until 30 days after the last administration of study treatment.

  18 months

• Economic evaluation

  18 months

Study Arms (1)

Panitumumab,capecitabine,oxaliplatin

EXPERIMENTAL

Panitumumab will be administered by IV infusion on day 1 of each 3-week cycle prior to the administration of chemotherapy. The starting panitumumab dose is 9 mg/kg. Oxaliplatin 130 mg/m2 IV infusion over 2 hours on Day 1 Capecitabine 2000 mg/m2 divided in two doses, orally, on Days 1 - 14

Drug: panitumumab

Interventions

panitumumab DRUG

Panitumumab will be administered by IV infusion on day 1 of each 3-week cycle prior to the administration of chemotherapy. The starting panitumumab dose is 9 mg/kg. Subjects with evidence of complete response, partial response or stable disease will continue to receive the combination of chemotherapy with panitumumab until disease progression, unacceptable toxicity or withdrawal of consent.

Panitumumab,capecitabine,oxaliplatin

Eligibility Criteria

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

You may qualify if:

• Ability to comprehend and sign an informed consent
• Aged 18 years or more
• Histologically or cytologically-confirmed metastatic adenocarcinoma of the colon and/or rectum
• Measurable disease according to the RECIST criteria
• Eastern Cooperative Oncology Group (ECOG) status of 0-2
• Non-mutated k-ras gene (k-ras status will be assessed by DNA sequencing in codons 12 and 13)
• Haematologic function: ANC \>1.5 x 109/L, Leucocyte count \>3000/mm3, Haemoglobin \>10g/ d L, PLT \>100 x 109/ L
• Renal function: serum creatinine ≤1.5xUNL or creatinine clearance \> 50ml/min
• 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
• Metabolic function:
• Magnesium ≥ lower limit of normal.
• Calcium ≥ lower limit of normal.

You may not qualify if:

• Central nervous system metastases
• Prior therapy for metastatic disease
• Adjuvant chemotherapy for the last 6 months
• Prior anti-EGFR therapy or treatment with EGFR tyrosine kinase inhibitors
• Prior radiotherapy within 30 days from enrollment
• Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) \<=1 year before enrollment
• History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
• Inflammatory bowel disease or chronic diarrhea
• Dihydropyrimidine deficiency
• Positive test for HIV infection, hepatitis C infection, chronic active hepatitis B infection
• Any kind of disorder compromising the ability of the patient to give informed consent
• Any investigational agent within 30 days prior to initiation of the study
• Any surgical procedure within 28 days prior to initiation of the study
• Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.
• Female subject in childbearing age with a positive pregnancy test at screening or before initiation of study treatment.

Sponsors & Collaborators

• Hellenic Cooperative Oncology Group: lead

Study Sites (12)

General Hospital of Athens "Hippokratio", 2nd Dept of Internal Medicine

Athens, 11527, Greece

Location

Sotiria General Hospital, 3rd Dept of Medicine, Oncology Unit

Athens, 11527, Greece

Location

General Peripheral Hospital of Athens "Alexandra"

Athens, 11528, Greece

Location

Agii Anargiri Cancer Hospital, Oncology Dept

Athens, 14564, Greece

Location

Hygeia Hospital, 2nd Dept of Medical Oncology

Athens, 15123, Greece

Location

Hygeia Hospital, 3rd Dept of Medical Oncology

Athens, 15123, Greece

Location

Metropolitan Hospital, 1st Dept of Medical Oncology

Athens, 18547, Greece

Location

Metropolitan Hospital, 2nd Dept of Medical Oncology

Athens, 18547, Greece

Location

Chania General Hospital

Chania, 73100, Greece

Location

Ioannina University Hospital, Dept of Medical Oncology

Ioannina, 45110, Greece

Location

Rio University Hospital, Dept of Oncology

Pátrai, 26500, Greece

Location

Papageorgiou General Hospital, Dept of Medical Oncology

Thessaloniki, 56429, Greece

Location

Related Publications (1)

• Papaxoinis G, Kotoula V, Giannoulatou E, Koliou GA, Karavasilis V, Lakis S, Koureas A, Bobos M, Chalaralambous E, Daskalaki E, Chatzopoulos K, Tsironis G, Pazarli E, Chrisafi S, Samantas E, Kaklamanos IG, Varthalitis I, Konstantara A, Syrigos KN, Pentheroudakis G, Pectasides D, Fountzilas G. Phase II study of panitumumab combined with capecitabine and oxaliplatin as first-line treatment in metastatic colorectal cancer patients: clinical results including extended tumor genotyping. Med Oncol. 2018 May 31;35(7):101. doi: 10.1007/s12032-018-1160-1.

  PMID: 29855806 DERIVED

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

• Dimitrios Pectasides, Professor

  General Hospital of Athens"Hippokratio", 2nd Dept of Internal Medicine

  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: September 29, 2010
• First Posted: October 6, 2010
• Study Start: September 1, 2010
• Primary Completion: August 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 18, 2015

Record last verified: 2015-03

Locations

GR (12)