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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2014-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Colorectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

panitumumab

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No