Pancreatic CancerPhase 2NCT00499265
Gemcitabine With or Without WX-671 in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed By Surgery
A Phase 2 study testing gemcitabine hydrochloride and Serine Proteinase Inhibitor WX-671 in people with Pancreatic Cancer, run by Heidelberg Pharma AG at 39 sites in 6 countries.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. WX-671 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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 hydrochloride and Serine Proteinase Inhibitor WX-671
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 39 sitesin 6 countries
- Study dates
- Apr 2007to May 2010
- 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
- Locally advanced, unresectable, non-metastatic, histologically proven pancreatic adenocarcinoma (lymph nodes will not be considered metastases)
- ECOG performance status ≤ 1
- Life expectancy > 12 weeks
- Normal 12-lead ECG or only clinically insignificant abnormalities in the judgment of the investigator
- Female patients of child-bearing potential will be required to use an effective method of birth control for the duration of the study to prevent pregnancy
- ANC ≥ 1,500/mm³
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- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 9 g/dL
- Total bilirubin ≤ 1.5 times ULN
- AST and ALT ≤ 2.5 times ULN
- Alkaline phosphatase ≤ 2.5 times ULN
- Creatinine ≤ 2 times ULN or creatinine clearance > 45 mL/min
Who cannot join
- Any distant metastases
- PATIENT CHARACTERISTICS:
- History of or current primary blood coagulation or bleeding disorders such as hemophilia
- Any unrelated illness, e.g., active infection, inflammation, medical condition or laboratory abnormalities, which in the judgment of the investigator might significantly affect the patient's study participation
- Any surgical or medical condition that might significantly alter the absorption, distribution, metabolism or excretion of any drug
- Significant cardiac insufficiency (NYHA classification III or IV), presence of unstable angina or myocardial infarction within the previous 6 months, use of ongoing maintenance therapy for life threatening arrhythmia or known pulmonary hypertension
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- Any secondary malignancies within the last 5 years except for surgically cured non-melanoma skin cancer or cervical carcinoma in situ
- Pregnancy (positive serum pregnancy test) or lactation
- Known hepatitis B/C or HIV infection
- Known hypersensitivity to any of the components in the anti-uPA serine protease inhibitor WX-671 capsules or gemcitabine hydrochloride infusion or other medical reasons for not being able to receive adequate pre-medication (for example, antihistamine or anti-inflammatory agents)
- PRIOR CONCURRENT THERAPY:
- Permitted:
- Growth factors for treatment (not prophylaxis, i.e., epoetin alfa), analgesics, blood transfusions, antibiotics, bisphosphonates, other hormonal therapy for contraceptive practice, replacement therapy such as thyroid replacement or adrenal insufficiency as appropriate and medications for acute or chronic conditions not listed under the exclusion criteria
- Embolization (i.e. for hematuria)
- Subjects can receive blood transfusions as medically appropriate during the study
- Subjects who require a blood transfusion during screening must have stable hemoglobin (≥9.0 g/dL [5.6 mmol/L]) without the need for further transfusions within 2 weeks before the first dose of anti-uPA serine protease inhibitor WX-671 to remain eligible
- Prophylactic use of growth factors to support neutrophils
- Prohibited:
- Anticoagulant or thrombolytic therapy within four weeks prior to start of treatment (except low dose anticoagulant therapy with unfractionated heparin ≤ 15000 IU/d, low molecular weight heparin ≤ 5000 IE anti-Xa activity or acetyl salicylic acid ≤ 100 mg/d at the discretion of the investigator)
- Anticancer therapies such as biologic therapy and chemotherapy (other than study drugs)
- Radiation therapy (during the treatment phase of the protocol; increased bone pain not controlled by medication and requiring palliative therapy will be considered disease progression)
- Laser treatment
- Any other investigational agent
- Thalidomide
- Immunosuppressive therapies (inhaled or replacement dose corticosteroids are permitted).
Trial locations and contacts
39 sites in 6 countries.
39 sites in 6 countries
Germany9 sites
Charite University Hospital - Campus Virchow Klinikum
Berlin, D-13353
Universitaetsklinikum Freiburg
Freiburg im Breisgau, D-79106
Otto-Meyerhof-Zentrum Tagesklinik
Heidelberg, 69120
Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg
Magdeburg, D-39120
Johannes Gutenberg University
Mainz, D-55101
III Medizinische Klinik Mannheim
Mannheim, D-68305
Klinikum der Universitaet Muenchen - Grosshadern Campus
Munich, D-81377
Klinikum Rechts Der Isar - Technische Universitaet Muenchen
Munich, D-81675
Hospital Muenchen Bogenhausen
Munich, D-81925
Ukraine8 sites
Cherkassy Regional Oncology Center
Cherkassy, 18009
Bukovinian State Medical University
Chernivtsy, 58002
Dnipropetrovsk State Medical Academy
Dnipropetrovsk, 49600
Donetsk Regional Antitumor Center
Donetsk, 83092
Ivano-Frankovsk Regional Oncology Center
Ivano-Frankivsk, 76018
Grigoriev Institute for Radiology Academy of Medical Science of Ukraine
Kharkiv, 61024
Institute of Oncology
Kiev, 03022
Ukrainian Medical Stomatological Academy
Poltava, 36024
Russia7 sites
Altai Oncology Center
Barnaul, 656049
Moscow Oncology Hospital
Moscow, 109033
Russian Academy of Medical Sciences Cancer Research Center
Moscow, 115478
Central Clinical Hospital of the President of the Russian Federation
Moscow, 121356
Rostov Research Institute of Oncology - Omsk
Omsk, 644013
Pavlov State Medical University
Saint Petersburg, 197089
Saint Petersburg State Medical University
Saint Petersburg, 197089
Hungary5 sites
Szent Laszlo Korhaz
Budapest, 1097
Debreceni Egyetem Onkologiai Tanzek
Debrecen, H-4012
Petz Aladar County Hospital
Gydr, h-9024
University of Pecs Faculty of Medicine
Pécs, H-7643
Szeged University
Szeged, H-6720
Italy5 sites
Centro di Riferimento Oncologico - Aviano
Aviano, 33081
Presidio Ospedaliero di Livorno
Livorno, 57100
Azienda Ospedaliera di Rilievo Nazionale A.Cardarelli
Naples, 80131
Istituto Tumori/Fondazione Pascale
Naples, 80131
Ospedale San Filippo Neri
Rome, 00135
Spain5 sites
Hospital de la Santa Cruz i Sant Pau
Barcelona, 08025
Vall d'Hebron University Hospital
Barcelona, 08035
Hospital Universitario de Elche
Elche, 03203
Hospital Virgen de las Nieves
Granada, 18014
Centro Oncologico M.D. Anderson International Espana
Madrid, 28033
About this study
Official title: A Randomized, Open Label, Phase II Proof of Concept Study of WX-671 in Combination With Gemcitabine vs.Gemcitabine Alone in Patients With Locally Advanced, Non Resectable Pancreatic Cancer in Order to Evaluate the Anti-Tumor Activity of the Combination Therapy
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. WX-671 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine together with WX-671 may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying how well gemcitabine works when given together with WX-671 or when given alone in treating patients with locally advanced pancreatic cancer that cannot be removed by surgery.
Read the detailed description
OBJECTIVES:
Primary
- Assess the antitumor activity of two different doses of anti-uPA serine protease inhibitor WX-671 when given in combination with gemcitabine hydrochloride in patients with locally advanced unresectable pancreatic cancer.
- Compare the efficacy, in terms of response rate, progression-free survival, time to first metastasis, overall survival, and tumor and uPA system-related markers, of these regimens in these patients.
- Compare the safety, in terms of vital signs, ECG, biochemistry, hematology (including coagulation), and adverse events, of these regimens.
OUTLINE: This is an open-label, randomized, multicenter study. Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients receive of oral anti-uPA serine protease inhibitor WX-671 once daily in weeks 1-8 (weeks 1-4 of each subsequent course) and gemcitabine hydrochloride IV over 30 minutes once weekly in weeks 1-7 (weeks 1-3 of each subsequent course) of course 1. All subsequent courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive oral anti-uPA serine protease inhibitor WX-671 (at a lower dose than in arm I) once daily in weeks 1-8 (weeks 1-4 of each subsequent course) and gemcitabine hydrochloride IV over 30 minutes once weekly in weeks 1-7 (weeks 1-3 of each subsequent course) of course 1. All subsequent courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
- Arm III: Patients receive gemcitabine hydrochloride IV over 30 minutes once weekly in weeks 1-7 (weeks 1-3 of each subsequent course) of course 1. All subsequent courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
- Conditions
- Pancreatic Cancer
- Being tested
- gemcitabine hydrochloride, Serine Proteinase Inhibitor WX-671
- Keywords
- recurrent pancreatic cancer, stage III pancreatic cancer, adenocarcinoma of the pancreas
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called GEMZAR
1000 mg/m2 as 30 min i.v. infusion once weekly for 7/8 weeks and then every 3/4 weeks
Serine Proteinase Inhibitor WX-671Drug
Also called MESUPRON
oral, daily
Serine Proteinase Inhibitor WX-671Drug
Also called MESUPRON
oral, daily
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine | Active comparator | Not described Receives: Drug: gemcitabine hydrochloride |
| Gemcitabine plus 200 mg WX-671 | Experimental | Not described Receives: Drug: Serine Proteinase Inhibitor WX-671 |
| Gemcitabine plus 400 mg WX-671 | Experimental | Not described Receives: Drug: Serine Proteinase Inhibitor WX-671 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy, in terms of response rate, progression-free survival, time to first metastasis, overall survival, and tumor and uPA system-related markers
Measured: 3 years
Safety, in terms of vital signs, ECG, biochemistry, hematology (including coagulation), and adverse events
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2007 (estimated)
- Study startApr 2007
- Primary completionMay 2010
- Study completionMay 2010
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
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg Pharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carola Mala, PhD, Study chair, Heidelberg Pharma AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00499265
- Sponsor's protocol ID
- CDR0000553460
- Other IDs
- WILEX-WX-60-004
- Status last verified
- Mar 2012
- First submitted
- 10 Jul 2007
- Last updated
- 29 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Phase II Proof of Concept Study of WX-671 in Combination With Gemcitabine vs.Gemcitabine Alone in Patients With Locally Advanced, Non Resectable Pancreatic Cancer in Order to Evaluate the Anti-Tumor Activity of the Combination Therapy
- ClinicalTrials.gov ID
- NCT00499265
- Acronym / sponsor ID
- CDR0000553460
- Conditions
- Pancreatic Cancer
- Keywords
- recurrent pancreatic cancer, stage III pancreatic cancer, adenocarcinoma of the pancreas
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Heidelberg Pharma AGIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 11 Jul 2007 (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.
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. WX-671 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine together with WX-671 may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying how well gemcitabine works when given together with WX-671 or when given alone in treating patients with locally advanced pancreatic cancer that cannot be removed by surgery.
Detailed description
OBJECTIVES:
Primary
- Assess the antitumor activity of two different doses of anti-uPA serine protease inhibitor WX-671 when given in combination with gemcitabine hydrochloride in patients with locally advanced unresectable pancreatic cancer.
- Compare the efficacy, in terms of response rate, progression-free survival, time to first metastasis, overall survival, and tumor and uPA system-related markers, of these regimens in these patients.
- Compare the safety, in terms of vital signs, ECG, biochemistry, hematology (including coagulation), and adverse events, of these regimens.
OUTLINE: This is an open-label, randomized, multicenter study. Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients receive of oral anti-uPA serine protease inhibitor WX-671 once daily in weeks 1-8 (weeks 1-4 of each subsequent course) and gemcitabine hydrochloride IV over 30 minutes once weekly in weeks 1-7 (weeks 1-3 of each subsequent course) of course 1. All subsequent courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive oral anti-uPA serine protease inhibitor WX-671 (at a lower dose than in arm I) once daily in weeks 1-8 (weeks 1-4 of each subsequent course) and gemcitabine hydrochloride IV over 30 minutes once weekly in weeks 1-7 (weeks 1-3 of each subsequent course) of course 1. All subsequent courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
- Arm III: Patients receive gemcitabine hydrochloride IV over 30 minutes once weekly in weeks 1-7 (weeks 1-3 of each subsequent course) of course 1. All subsequent courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine | Active comparator | Drug: gemcitabine hydrochloride |
| Gemcitabine plus 200 mg WX-671 | Experimental | Drug: Serine Proteinase Inhibitor WX-671 |
| Gemcitabine plus 400 mg WX-671 | Experimental | Drug: Serine Proteinase Inhibitor WX-671 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
Key exclusion criteria (25 listed)
- Permitted:
- Prohibited:
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 hydrochlorideAlso: GEMZAR1000 mg/m2 as 30 min i.v. infusion once weekly for 7/8 weeks and then every 3/4 weeks | Drug | Gemcitabine |
| Serine Proteinase Inhibitor WX-671Also: MESUPRONoral, daily | Drug | Gemcitabine plus 200 mg WX-671 |
| Serine Proteinase Inhibitor WX-671Also: MESUPRONoral, daily | Drug | Gemcitabine plus 400 mg WX-671 |
Primary outcome
Efficacy, in terms of response rate, progression-free survival, time to first metastasis, overall survival, and tumor and uPA system-related markers
Time frame: 3 years
Safety, in terms of vital signs, ECG, biochemistry, hematology (including coagulation), and adverse events
Time frame: 3 years
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 29 Mar 2012.
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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.
Carola Mala, PhD study chair
Heidelberg Pharma AG
39 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing gemcitabine hydrochloride and Serine Proteinase Inhibitor WX-671 in people with Pancreatic Cancer, run by Heidelberg Pharma AG at 39 sites in 6 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 12 inclusion and 25 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 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in Germany, Ukraine, Russia, Hungary, Italy and 1 more country. 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?
Efficacy, in terms of response rate, progression-free survival, time to first metastasis, overall survival, and tumor and uPA system-related markers (time frame: 3 years). The study lists 2 primary outcomes in all. 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 29 Mar 2012.