Pancreatic CancerPhase 2NCT00673504
First-Line Gemcitabine Chemotherapy With Our Without Sunitinib In Advanced or Metastatic Pancreatic Cancer
A Phase 2 study testing Gemcitabine + Sunitinib and Gemcitabine in people with Pancreatic Cancer, run by Central European Society for Anticancer Drug Research at 11 sites in 2 countries.
Trial 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. 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 + Sunitinib and Gemcitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 11 sitesin 2 countries
- Study dates
- Apr 2008to Nov 2011
- Phase
- Phase 2
- 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 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.
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- 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
Who cannot join
- Resectable pancreatic cancer
- Previous chemotherapy (for adjuvant or metastatic disease)
- Any investigational drug within the 30 days before inclusion.
- 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.
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- 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)
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
Germany10 sites
Städtisches Klinikum Braunschweig
Braunschweig, 38114
Universitätsklinikum Essen
Essen, 45122
Krankenhaus
Frankfurt, 60488
Klinikum der J. W. Goethe Universität; Zentrum der Inneren Medizin
Frankfurt, 60590
Internistisches Facharztzentrum
Frankfurt, 60596
Martin-Luther-Universität Halle-Wittenberg; Medizinische Fakultät
Halle, 06097
Facharztpraxis
Heidelberg, 69115
Klinikum Lüdenscheid
Lüdenscheid, 58515
Klinikum Nürnberg Nord
Nuremberg, 90419
Robert-Bosch-Krankenhaus
Stuttgart, 70376
About this study
Official title: Prospective Randomized Phase II Trial With Gemcitabine Plus Sunitinib Versus Gemcitabine Alone in First-line Therapy of Metastatic or Locally Advanced Pancreatic Cancer
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
- Being tested
- Gemcitabine + Sunitinib, Gemcitabine
- Keywords
- cancer, pancreatic cancer, gemcitabine, sunitinib, Phase 2
- Medical subject headings
- Pancreatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemcitabine + SunitinibDrug
Gemcitabine 1.000 mg/m2, d1,8q3weeks Sunitinib 50 mg/day (2weeks on/1weeks off)
GemcitabineDrug
1.000 mg/m2 d1,8,15q4weeks
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Gemcitabine + Sunitinib Receives: Drug: Gemcitabine + Sunitinib |
| B | Other | Gemcitabine Receives: Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Progression
Measured: once all patients completed treatment
Secondary outcomes (3)
Response Rate (RR)
Measured: once all patients completed treatment
overall survival
Measured: at study end
Safety
Measured: at study end
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2008 (estimated)
- Study startApr 2008
- Primary completionOct 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central European Society for Anticancer Drug Research
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00673504
- Sponsor's protocol ID
- C-II-004 / 2007-005022-71
- Status last verified
- Nov 2011
- First submitted
- 6 May 2008
- Last updated
- 1 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Phase II Trial With Gemcitabine Plus Sunitinib Versus Gemcitabine Alone in First-line Therapy of Metastatic or Locally Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00673504
- Acronym / sponsor ID
- C-II-004 / 2007-005022-71
- Conditions
- Pancreatic Cancer
- Keywords
- cancer, pancreatic cancer, gemcitabine, sunitinib, Phase 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Central European Society for Anticancer Drug ResearchUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Oct 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 7 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Gemcitabine + SunitinibGemcitabine + Sunitinib |
| B | Other | Drug: GemcitabineGemcitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (15 listed)
- Resectable pancreatic cancer
- Previous chemotherapy (for adjuvant or metastatic disease)
- Any investigational drug within the 30 days before inclusion.
- Prior use of sunitinib or other multitarget tyrosine kinase inhibitor
- Pregnancy (absence to be confirmed by beta-hCG test) or lactation period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gemcitabine + SunitinibGemcitabine 1.000 mg/m2, d1,8q3weeks Sunitinib 50 mg/day (2weeks on/1weeks off) | Drug | A |
| Gemcitabine1.000 mg/m2 d1,8,15q4weeks | Drug | B |
Primary outcome
Time to Progression
Time frame: once all patients completed treatment
3 secondary outcomes
Response Rate (RR)
Time frame: once all patients completed treatment
overall survival
Time frame: at study end
Safety
Time frame: at study end
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2011.
- German Study Description on CESAR's homepageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gemcitabine + Sunitinib and Gemcitabine in people with Pancreatic Cancer, run by Central European Society for Anticancer Drug Research at 11 sites in 2 countries.
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 9 inclusion and 15 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 1 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Germany, Switzerland. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Time to Progression (time frame: once all patients completed treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Dec 2011.