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

Primary Purpose

Colorectal Cancer

Status

Completed

Phase

Phase 2

Locations

Greece

Study Type

Interventional

Intervention

panitumumab

About this trial

This is an interventional treatment trial for Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.
Subject (male or female) 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.

Sites / Locations

General Hospital of Athens "Hippokratio", 2nd Dept of Internal Medicine
Sotiria General Hospital, 3rd Dept of Medicine, Oncology Unit
General Peripheral Hospital of Athens "Alexandra"
Agii Anargiri Cancer Hospital, Oncology Dept
Hygeia Hospital, 2nd Dept of Medical Oncology
Hygeia Hospital, 3rd Dept of Medical Oncology
Metropolitan Hospital, 1st Dept of Medical Oncology
Metropolitan Hospital, 2nd Dept of Medical Oncology
Chania General Hospital
Ioannina University Hospital, Dept of Medical Oncology
Rio University Hospital, Dept of Oncology
Papageorgiou General Hospital, Dept of Medical Oncology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Panitumumab,capecitabine,oxaliplatin

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall Survival (OS)

OS will be calculated from the date of enrolment to the date of death or last contact

Progression-Free Survival(PFS)

PFS will be calculated from the date of enrolment to the date of disease progression, or death, or last contact. Deaths without a documented progression will be treated as events at the time of death for the PFS analysis. Time to event distributions will be estimated using the Kaplan-Meier method.

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.

Adverse Events will be graded according to the NCI CTCAE v3.0 criteria and will be reported in a frequency table according to the highest severity grade observed per patient

Economic evaluation

The purpose of economic evaluation will be to estimate the total treatment cost of therapy and its componenents from perspective of the health care system and payers. Thus, all resources consumed will be valued to get an idea of the financial implications of therapy.

Full Information

NCT ID

NCT01215539

First Posted

September 29, 2010

Last Updated

March 17, 2015

Sponsor

Hellenic Cooperative Oncology Group

1. Study Identification

Unique Protocol Identification Number

NCT01215539

Brief Title

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

Official Title

A SINGLE-ARM, MULTICENTER, PHASE II STUDY OF PANITUMUMAB IN COMBINATION WITH CAPECITABINE / OXALIPLATIN IN FIRST-LINE, WILD-TYPE K-RAS METASTATIC COLORECTAL CANCER PATIENTS.

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

September 2010 (undefined)

Primary Completion Date

August 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hellenic Cooperative Oncology Group

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

This is a single-arm trial in which previously untreated, wild-type k-ras metastatic colorectal cancer patients will receive therapy with the combination of panitumumab with capecitabine and oxaliplatin. During the treatment period of 6 cycles, 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. Those patients with disease stabilization who are not appropriate for chemotherapy may continue with panitumumab alone. Patients with disease progression will be discontinued from chemotherapy and panitumumab and will be followed every 3 months after the last drug administration until death. Tumor response will be assessed according to the RECIST criteria (investigator's read of scans), every 6 weeks through week 18 and every 3 months thereafter, until disease progression. Disease progression will also be evaluated radiographically at the time of clinical suspicion of progression.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

78 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Panitumumab,capecitabine,oxaliplatin

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

panitumumab

Intervention Description

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.

Primary Outcome Measure Information:

Title

Objective Response

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

Overall Survival (OS)

Description

OS will be calculated from the date of enrolment to the date of death or last contact

Time Frame

24 months

Title

Progression-Free Survival(PFS)

Description

Time Frame

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

Title

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.

Description

Adverse Events will be graded according to the NCI CTCAE v3.0 criteria and will be reported in a frequency table according to the highest severity grade observed per patient

Time Frame

18 months

Title

Economic evaluation

Description

Time Frame

18 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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. Subject (male or female) 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dimitrios Pectasides, Professor

Organizational Affiliation

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

Official's Role

Study Chair

Facility Information:

Facility Name

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

City

Athens

ZIP/Postal Code

11527

Country

Greece

Facility Name

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

City

Athens

ZIP/Postal Code

11527

Country

Greece

Facility Name

General Peripheral Hospital of Athens "Alexandra"

City

Athens

ZIP/Postal Code

11528

Country

Greece

Facility Name

Agii Anargiri Cancer Hospital, Oncology Dept

City

Athens

ZIP/Postal Code

14564

Country

Greece

Facility Name

Hygeia Hospital, 2nd Dept of Medical Oncology

City

Athens

ZIP/Postal Code

15123

Country

Greece

Facility Name

Hygeia Hospital, 3rd Dept of Medical Oncology

City

Athens

ZIP/Postal Code

15123

Country

Greece

Facility Name

Metropolitan Hospital, 1st Dept of Medical Oncology

City

Athens

ZIP/Postal Code

18547

Country

Greece

Facility Name

Metropolitan Hospital, 2nd Dept of Medical Oncology

City

Athens

ZIP/Postal Code

18547

Country

Greece

Facility Name

Chania General Hospital

City

Chania

ZIP/Postal Code

73100

Country

Greece

Facility Name

Ioannina University Hospital, Dept of Medical Oncology

City

Ioannina

ZIP/Postal Code

45110

Country

Greece

Facility Name

Rio University Hospital, Dept of Oncology

City

Patras

ZIP/Postal Code

26500

Country

Greece

Facility Name

Papageorgiou General Hospital, Dept of Medical Oncology

City

Thessaloniki

ZIP/Postal Code

56429

Country

Greece

12. IPD Sharing Statement

Citations:

PubMed Identifier

29855806

Citation

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.

Results Reference

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

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