First-Line Gemcitabine Chemotherapy With Our Without Sunitinib In Advanced or Metastatic Pancreatic Cancer

NCT00673504 | Completed Phase 2

• 1 other identifier: C-II-004 / 2007-005022-71
• Study Type: interventional
• Target: 105
• Locations: 2 countries
• Sites: 11

Brief Summary

Primary objective: to evaluate whether the addition of sunitinib prolongates the Progression-Free Survival (PFS) in patients with advanced pancreatic cancer receiving first-line gemcitabine chemotherapy.

Conditions

Pancreatic Cancer

Keywords

cancer; pancreatic cancer; gemcitabine; sunitinib; Phase 2

Outcome Measures

Primary Outcomes (1)

• Time to Progression

  once all patients completed treatment

Secondary Outcomes (3)

• Response Rate (RR)

  once all patients completed treatment

• overall survival

  at study end

• Safety

  at study end

Study Arms (2)

A

EXPERIMENTAL

Gemcitabine + Sunitinib

Drug: Gemcitabine + Sunitinib

B

OTHER

Gemcitabine

Drug: Gemcitabine

Interventions

Gemcitabine + Sunitinib DRUG

Gemcitabine 1.000 mg/m2, d1,8q3weeks Sunitinib 50 mg/day (2weeks on/1weeks off)

A

Gemcitabine DRUG

1.000 mg/m2 d1,8,15q4weeks

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who suffer from locally advanced or metastatic pancreatic cancer
• Patients with measurable disease (at least one uni-dimensionally measurable target lesion by CT-scan or MRI) according to Response Evaluation Criteria in Solid Tumors (RECIST).
• ECOG performance status 0 to 1
• Signed written informed consent.
• White blood cell count (WBC) \>= 3x10\^9/L with neutrophils \>= 1.5 x 10\^9/L, platelet count \>= 100x10\^9/L, hemoglobin \>= 5.6 mmol/L (9 g/dL).
• Total bilirubin \< 2 x upper limit of normal.
• AST and ALT \< 2.5 x upper limit of normal, or \< 5 x upper limit of normal in case of liver metastases.
• Serum creatinine \< 1.5 x upper limit of normal
• Normal ECG without QT prolongation

You may not qualify if:

• Resectable pancreatic cancer
• Previous chemotherapy (for adjuvant or metastatic disease)
• Prior use of sunitinib or other multitarget tyrosine kinase inhibitor
• Pregnancy (absence to be confirmed by beta-hCG test) or lactation period.
• Men or women of child-bearing potential who are sexually active and unwilling to use a medically acceptable method of contraception during the trial.
• Clinically symptomatic brain or meningeal metastasis. (known or suspected)
• Cardiac arrhythmias requiring anti-arrhythmics (excluding beta blockers or digoxin).
• History of any of the following cardiac events within the past 6 months: myocardial infarction (including severe/unstable angina; coronary/peripheral artery bypass graft; symptomatic congestive heart failure (CHF) \> NYHA Class II; cerebrovascular accident or transient ischemic attack; pulmonary embolism
• Uncontrolled severe hypertension (failure of diastolic blood pressure to fall below 90 mm Hg despite the use of up to 3 anti-hypertensive drugs
• Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease or chronic diarrhea
• Previous malignancy (other than pancreatic cancer) in the last 5 years except basal cell cancer of the skin, pre-invasive cancer of the cervix or superficial bladder tumor \[Ta, Tis and T1\].
• History of organ allograft
• Patients requiring long-term cortisone therapy
• Patients requiring oral anticoagulation treatment (such as marcoumar)

Sponsors & Collaborators

• Central European Society for Anticancer Drug Research: lead

Study Sites (11)

Städtisches Klinikum Braunschweig

Braunschweig, 38114, Germany

Location

Universitätsklinikum Essen

Essen, 45122, Germany

Location

Krankenhaus

Frankfurt, 60488, Germany

Location

Klinikum der J. W. Goethe Universität; Zentrum der Inneren Medizin

Frankfurt, 60590, Germany

Location

Internistisches Facharztzentrum

Frankfurt, 60596, Germany

Location

Martin-Luther-Universität Halle-Wittenberg; Medizinische Fakultät

Halle, 06097, Germany

Location

Facharztpraxis

Heidelberg, 69115, Germany

Location

Klinikum Lüdenscheid

Lüdenscheid, 58515, Germany

Location

Klinikum Nürnberg Nord

Nuremberg, 90419, Germany

Location

Robert-Bosch-Krankenhaus

Stuttgart, 70376, Germany

Location

Kantonsspital St. Gallen

Sankt Gallen, 9007, Switzerland

Location

Related Links

• German Study Description on CESAR's homepage

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasms

Interventions

Gemcitabine; Sunitinib

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Pyrroles; Azoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 6, 2008
• First Posted: May 7, 2008
• Study Start: April 1, 2008
• Primary Completion: October 1, 2011
• Study Completion: November 1, 2011
• Last Updated: December 1, 2011

Record last verified: 2011-11

Locations

DE (10); CH (1)