NCT00789763

Brief Summary

Phase I: Safety profile and to determine maximum tolerated dose (MTD) / Recommended Dose (DR) of Sorafenib in combination with Gemcitabine and Radiotherapy Phase II: Activity profile evaluating Progression-free rates (PFR) at 6 months, Response rate, Overall survival, Toxicity profile

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 pancreatic-cancer

Timeline
Completed

Started Dec 2007

Typical duration for phase_1 pancreatic-cancer

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 11, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 13, 2008

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

November 29, 2012

Status Verified

November 1, 2012

Enrollment Period

3.1 years

First QC Date

November 11, 2008

Last Update Submit

November 28, 2012

Conditions

Pancreatic Cancer

Keywords

pancreatic cancerPancreatic cancer locally advanced

Outcome Measures

Primary Outcomes (3)

  • SAFETY

    End of Study

  • EFFICACY

    End of Study

  • TO DETERMINE MTD

    Treatment (5 weeks)

Secondary Outcomes (1)

  • RESPONSE (ACCORDING TO RECIST)

    End of Study

Study Arms (1)

Sorafenib + gemcitabine + radiotherapy

EXPERIMENTAL
Drug: GemcitabineRadiation: RadiotherapyDrug: Sorafenib

Interventions

GemcitabineDRUG

300 mg/m2/one per week, i.v., during 5 weeks.

Sorafenib + gemcitabine + radiotherapy
RadiotherapyRADIATION

1.8 Gy/day 5 days per week during 5 weeks (total dose 45Gy)

Sorafenib + gemcitabine + radiotherapy
SorafenibDRUG

200-800 mg/day p.o. during 5 weeks

Also known as: Brand name: nexavar
Sorafenib + gemcitabine + radiotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with histological or cytological confirmed locally advanced pancreatic adenocarcinoma pancreatic carcinoma or metastatic pancreatic carcinoma for phase I.
  • Patients with measurable (according to RECIST) disease.
  • Male or female patients \> or = 18 years old
  • ECOG 0-1
  • Adequate bone marrow, liver , and renal function: Absolute neutrophil count ( ANC) \>= 1,500/mm3 Platelets\> or = 100,000/µl Hemoglobin \>=9.0 g/dl Total bilirubin \< 1.5 x the upper limit of normal. ALT and AST \<= 2.5 x upper limit of normal ( \<= 5X upper limit of normal for patients with liver involvement ) Serum creatinine \<= 1.5 times x the upper limit of normal. Patients with creatinine clearance \>= 45mL/min PT( prothrombin time ) or INR( international normalized ratio ) and PTT ( partial thromboplastin time ) \< =1.5 x
  • Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation. Men should use adequate birth control for at least six months after the last administration of sorafenib
  • Signed informed consent prior to any study specific procedures

You may not qualify if:

  • Patients with previous treatment for pancreatic carcinoma
  • PTV ( planning target volume ) \>500 cm3 or 5 cm (maximum diameter)
  • Patients with known or suspected allergy to iodated contrasts or renal impairment which prevents from radiological tests.
  • Pregnant or nursing patients. Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment
  • General medical or psychological conditions that would preclude appropriate informed consent or compliance with the protocol.
  • Previous cancer that is distinct in primary site or histology from NSCLC except cervical cancer in-situ, treated basal cell carcinoma, superficial bladder tumors (Ta and Tis) or any cancer curatively treated \> 3 years prior to study entry
  • Concurrent treatment with other experimental drugs (within 30 days prior to study entry).
  • Concurrent treatment with other anti-cancer therapy.
  • Therapeutic anticoagulation with Vitamin K antagonists such as warfarin or with heparins or heparinoids. Low dose warfarin is permitted if INR is \<1.5 . Low dose aspirin is permitted .
  • Patients with any medical condition which could jeopardize their safety while his participation in the study .
  • Significant weight loss (\> or equal 10% body weight during preceding 6 weeks)
  • Major surgery within 3 previous weeks, or laparoscopic biopsy or significant traumatic injury within 2 weeks of prior to first dose of study drug.
  • Known or suspected allergy to sorafenib or any agent given in the course of this trial .
  • Patients with evidence or history of bleeding diathesis or coagulopathy
  • Thrombotic or embolic events such as cerebrovascular accident including transient ischemic attacks within the past 6 months
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hospital de La Santa Creu I Sant Pau

Barcelona, Barcelona, 08025, Spain

Location

Hospital Clinic I Provincial

Barcelona, Barcelona, 08036, Spain

Location

Hospital Universitario La Paz

Madrid, Madrid, 28046, Spain

Location

Hospital Universitario La Fe

Valencia, Valencia, 46009, Spain

Location

Related Publications (1)

  • Aparicio J, Garcia-Mora C, Martin M, Petriz ML, Feliu J, Sanchez-Santos ME, Ayuso JR, Fuster D, Conill C, Maurel J. A phase I, dose-finding study of sorafenib in combination with gemcitabine and radiation therapy in patients with unresectable pancreatic adenocarcinoma: a Grupo Espanol Multidisciplinario en Cancer Digestivo (GEMCAD) study. PLoS One. 2014 Jan 9;9(1):e82209. doi: 10.1371/journal.pone.0082209. eCollection 2014.

    PMID: 24416138DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

GemcitabineRadiotherapySorafenib

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingTherapeuticsPhenylurea CompoundsUreaAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNiacinamideNicotinic AcidsAcids, HeterocyclicPyridines

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2008

First Posted

November 13, 2008

Study Start

December 1, 2007

Primary Completion

January 1, 2011

Study Completion

January 1, 2012

Last Updated

November 29, 2012

Record last verified: 2012-11

Locations

ES(4)