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Pancreatic CancerPhase 1NCT00789763

Phase I-II to Evaluate Efficacy/Safety of Sorafenib+Gemcitabine+Radiotherapy in Locally Advanced Pancreatic Carcinoma

A Phase 1 study testing Gemcitabine, Radiotherapy and Sorafenib in people with Pancreatic Cancer, run by Grupo Espanol Multidisciplinario del Cancer Digestivo at 4 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
Gemcitabine, Radiotherapy and Sorafenib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
4 sitesSpain
Study dates
Dec 2007to Jan 2012
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • -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

Who cannot join

  • -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
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  • -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
  • -Uncontrolled hypertension defined as systolic blood pressure > 150 mm Hg or diastolic pressure > 90 mm Hg, despite optimal medical management
  • -Cardiac disease: Congestive heart failure > class II NYHA. Patients must not have unstable angina or new-onset angina (began within the last 3 months) or myocardial infarction within the last 6 months
  • -Patients with Child-Pugh class C hepatic impairment
  • -Patients with severe renal impairment (calculated creatinine clearance of < 30 ml/min) or who require dialysis
  • -Active clinically serious infections > CTCAE Grade 2
  • -Serious, non-healing wound, ulcer, or bone fracture
  • -Patients with concomitant ketoconazole, itraconazole,ritonavir,rifampicin or St. John's Wort (Hypericum perforatum).
  • -Known brain metastasis. Patients with neurological symptoms should undergo a CT scan/MRI of the brain to exclude brain metastasis
  • -Any instable condition that may interfere with the patients participation in the study

Trial locations and contacts

4 sites in 1 country.

Spain4 sites

  • Hospital de La Santa Creu I Sant Pau

    Barcelona, Barcelona, 08025

  • Hospital Clinic I Provincial

    Barcelona, Barcelona, 08036

  • Hospital Universitario La Paz

    Madrid, Madrid, 28046

  • Hospital Universitario La Fe

    Valencia, Valencia, 46009

Other trials in Spain

About this study

Official title: Open-label, Multicentric Phase I-II Trial to Evaluate the Efficacy and Safety of the Combination of Sorafenib (BAY 43-9006), Gemcitabine and Concurrent Radiotherapy, in Locally Advanced Pancreatic Carcinoma

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

Read the detailed description

Safety profile and to determine maximum tolerated dose (MTD) / Recommended Dose (DR) of Sorafenib in combination with Gemcitabine and Radiotherapy

Definition of maximum tolerated dose (MTD):

The MTD is defined as the highest dose level which can be given to 6 patients such that no more than 1 patient experiences a DLT .

Definition of Recommended Dose (DR):

Is the MTD

Definition of Dose-limiting toxicity (DLT):

DLT will be defined as any of the following occurring during the period of treatment and regarded as related to the combination regimen.

  • Grade 4 thrombocytopenia persisting greater than 4 days, or with bleeding requiring platelet transfusion
  • Grade 4 neutropenia lasting more than 7 days
  • Febrile neutropenia (≥ 38.5oC) with an absolute neutrophil count ≤ 1000/mm3
  • Any grade 3 or 4 non-hematologic toxicity related to the combination [occurring despite optimal supportive care, if applicable] except hyperglycemia, hypoglycemia, deep venous thrombosis, or hyperbilirubinemia secondary to stent malfunction.
  • Hypertension that is symptomatic and not managed by maximal use of three different classes of antihypertensives, or any episode of malignancy hypertension (Detailed Dose Modifications and G-CSF use in case of febrile neutropenia will be outlined in the full protocol version)

Phase II

Primary objective:

Activity profile evaluating Progression-free rates (PFR) at 6 months

Secondary objective:

Response rate Overall survival Toxicity profile

Being tested
Gemcitabine, Radiotherapy, Sorafenib
Keywords
pancreatic cancer, Pancreatic cancer locally advanced
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GemcitabineDrug

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

  • RadiotherapyRadiation

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

  • SorafenibDrug

    Also called Brand name: nexavar

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

Study groups in NCT00789763
Study groupRoleWhat they receive
Sorafenib + gemcitabine + radiotherapyExperimentalNot described
Receives: Drug: Gemcitabine; Radiation: Radiotherapy; Drug: Sorafenib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. SAFETY

    Measured: End of Study

  2. EFFICACY

    Measured: End of Study

  3. TO DETERMINE MTD

    Measured: Treatment (5 weeks)

Secondary outcomes (1)

  1. RESPONSE (ACCORDING TO RECIST)

    Measured: End of Study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2008 (estimated)
  2. Study startDec 2007
  3. Primary completionJan 2011
  4. Study completionJan 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00789763
Sponsor's protocol ID
GEMCAD 0701
Status last verified
Nov 2012
First submitted
11 Nov 2008
Last updated
29 Nov 2012
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 24416138

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Gemcitabine, Radiotherapy and Sorafenib in people with Pancreatic Cancer, run by Grupo Espanol Multidisciplinario del Cancer Digestivo at 4 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SAFETY (time frame: End of Study). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00789763, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2012.

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