Know Cancer

or
forgot password

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.


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer

Thank you

Trial Information

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.


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.


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective Response

Outcome Description:

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.

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Dimitrios Pectasides, Professor

Investigator Role:

Study Chair

Investigator Affiliation:

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

Authority:

Greece: Ethics Committee

Study ID:

HE 6A/09

NCT ID:

NCT01215539

Start Date:

September 2010

Completion Date:

June 2014

Related Keywords:

  • Colorectal Cancer
  • Colorectal Neoplasms

Name

Location