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Trial record 66 of 435 for:    colon cancer AND Capecitabine

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

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ClinicalTrials.gov Identifier: NCT01215539
Recruitment Status : Completed
First Posted : October 6, 2010
Last Update Posted : March 18, 2015
Sponsor:
Information provided by (Responsible Party):
Hellenic Cooperative Oncology Group

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: panitumumab Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2010
Actual Primary Completion Date : August 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Panitumumab,capecitabine,oxaliplatin

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
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 Measures :
  1. Objective Response [ Time Frame: Tumor response will be assessed every 6 weeks through week 18 and every 3 months thereafter, until disease progression. ]

    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 :
  1. Overall Survival (OS) [ Time Frame: 24 months ]
    OS will be calculated from the date of enrolment to the date of death or last contact

  2. Progression-Free Survival(PFS) [ Time Frame: Tumor response will be assessed every 6 weeks through week 18 and every 3 months thereafter, until disease progression. ]

    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.


  3. 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. [ Time Frame: 18 months ]
    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

  4. Economic evaluation [ Time Frame: 18 months ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Ability to comprehend and sign an informed consent
  2. Aged 18 years or more
  3. Histologically or cytologically-confirmed metastatic adenocarcinoma of the colon and/or rectum
  4. Measurable disease according to the RECIST criteria
  5. Eastern Cooperative Oncology Group (ECOG) status of 0-2
  6. Non-mutated k-ras gene (k-ras status will be assessed by DNA sequencing in codons 12 and 13)
  7. Haematologic function: ANC >1.5 x 109/L, Leucocyte count >3000/mm3, Haemoglobin >10g/ d L, PLT >100 x 109/ L
  8. Renal function: serum creatinine ≤1.5xUNL or creatinine clearance > 50ml/min
  9. 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
  10. Metabolic function:

    • Magnesium ≥ lower limit of normal.
    • Calcium ≥ lower limit of normal.

Exclusion Criteria:

  1. Central nervous system metastases
  2. Prior therapy for metastatic disease
  3. Adjuvant chemotherapy for the last 6 months
  4. Prior anti-EGFR therapy or treatment with EGFR tyrosine kinase inhibitors
  5. Prior radiotherapy within 30 days from enrollment
  6. Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) <=1 year before enrollment
  7. History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
  8. Inflammatory bowel disease or chronic diarrhea
  9. Dihydropyrimidine deficiency
  10. Positive test for HIV infection, hepatitis C infection, chronic active hepatitis B infection
  11. Any kind of disorder compromising the ability of the patient to give informed consent
  12. Any investigational agent within 30 days prior to initiation of the study
  13. Any surgical procedure within 28 days prior to initiation of the study
  14. Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.
  15. Female subject in childbearing age with a positive pregnancy test at screening or before initiation of study treatment.
  16. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01215539


Locations
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Greece
General Hospital of Athens "Hippokratio", 2nd Dept of Internal Medicine
Athens, Greece, 11527
Sotiria General Hospital, 3rd Dept of Medicine, Oncology Unit
Athens, Greece, 11527
General Peripheral Hospital of Athens "Alexandra"
Athens, Greece, 11528
Agii Anargiri Cancer Hospital, Oncology Dept
Athens, Greece, 14564
Hygeia Hospital, 2nd Dept of Medical Oncology
Athens, Greece, 15123
Hygeia Hospital, 3rd Dept of Medical Oncology
Athens, Greece, 15123
Metropolitan Hospital, 1st Dept of Medical Oncology
Athens, Greece, 18547
Metropolitan Hospital, 2nd Dept of Medical Oncology
Athens, Greece, 18547
Chania General Hospital
Chania, Greece, 73100
Ioannina University Hospital, Dept of Medical Oncology
Ioannina, Greece, 45110
Rio University Hospital, Dept of Oncology
Patras, Greece, 26500
Papageorgiou General Hospital, Dept of Medical Oncology
Thessaloniki, Greece, 56429
Sponsors and Collaborators
Hellenic Cooperative Oncology Group
Investigators
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Study Chair: Dimitrios Pectasides, Professor General Hospital of Athens"Hippokratio", 2nd Dept of Internal Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hellenic Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT01215539     History of Changes
Other Study ID Numbers: HE 6A/09
2009-012655-26 ( EudraCT Number )
First Posted: October 6, 2010    Key Record Dates
Last Update Posted: March 18, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Capecitabine
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Oxaliplatin
Panitumumab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Immunological