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Ensayo Fase II de selección Individualizada Del Tratamiento de Quimioterapia en Pacientes Con Carcinoma de páncreas Avanzado en función de la determinación de Dianas terapéuticas en el Tejido Tumoral


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Advanced Pancreatic Carcinoma

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Trial Information

Ensayo Fase II de selección Individualizada Del Tratamiento de Quimioterapia en Pacientes Con Carcinoma de páncreas Avanzado en función de la determinación de Dianas terapéuticas en el Tejido Tumoral


Phase II, open two branches, in which conventional treatment is administered to patients
diagnosed with metastatic pancreatic carcinoma. Patients will be randomized (1:1) to a
treatment arm or control arm of experimental treatment guided by the therapeutic targets.
Patients in the control treatment arm will be treated with any of the schemes used in the
study according to the discretion of the physician responsible. Patients will be analyzed as
"intention to treat." In the experimental treatment arm (therapeutic targets) and within 15
days will determine the markers of therapeutic targets detailed in the protocol, either from
pre-existing tumor sample or a fresh sample obtained by biopsy. Based on the results of this
analysis, we prescribe a chemotherapy treatment determined for possible treatments currently
used in pancreatic carcinoma, gemcitabine, gemcitabine and capecitabine, gemcitabine and
erlotinib, FOLFIRINOX, FOLFOX, FOLFIRI.

Treatment duration is indefinite .


Inclusion Criteria:



- Histological or cytological diagnosis of pancreatic carcinoma.

- Patients> 18 years.

- Measurable or not measurable disease.

- Life expectancy> 3 months at the discretion of the investigator.

- Good general condition determined by the ECOG scale (score 0-1)

- Candidate for first-line systemic chemotherapy according to standard practice.

- Availability of tumor tissue or opportunity for tumor biopsy for the - determination
of biomarkers and their correlation with treatment.

- Adequate hematologic function: ANC> 1.5 x 103 / L, absolute count of platelets> 100 x
109 / L, normal values ​​of INR and PTT.

- Adequate liver function: total serum bilirubin <2 mg / dL, ALT and AST <3 times the
upper limit established by the laboratory (LSR) or <5 LSR in patients with liver
metastases.

- Adequate renal function: serum creatinine <1.5 LSR.

Exclusion Criteria:

- Patients who have received prior chemotherapy for advanced pancreatic carcinoma. Will
not result excluding patients who had previously received adjuvant treatment with
gemcitabine or fluoropyrimidines. Also not will be excluded patients who had
previously received preoperative neoadjuvant treatment for localized disease with
chemotherapy and / or radiotherapy.

- Patients for whom is contraindicated the administration of either drug used in
first-line treatment for pancreatic cancer: Gemcitabine, 5'Fluouracilo, Leucovorin,
Capecitabine, Oxaliplatin, Irinotecan, Erlotinib.

- Pregnant or breastfeeding women

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Description:

The primary endpoint is survival as measured from the start of treatment the patient to the death of the patient according to the Kaplan-Meier. For each treatment arm will determine the overall survival and the survival and actuarial survival at one year

Outcome Time Frame:

12 months

Safety Issue:

Yes

Principal Investigator

Manuel Hidalgo, M.D.,PhD

Investigator Role:

Study Director

Investigator Affiliation:

CNIO

Authority:

Spain: Spanish Agency of Medicines

Study ID:

CNIO-GI-01-2011

NCT ID:

NCT01454180

Start Date:

October 2011

Completion Date:

October 2012

Related Keywords:

  • Advanced Pancreatic Carcinoma
  • Therapeutic targets in Pancreas
  • Carcinoma
  • Pancreatic Neoplasms

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