Pancreatic CancerPhase 3NCT00541021
Gemcitabine With or Without Sorafenib in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
A Phase 3 study testing gemcitabine hydrochloride and sorafenib tosylate in people with Pancreatic Cancer, run by Institut Paoli-Calmettes at 1 site in France.
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. 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 sorafenib tosylate
- How many people
- 104 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2006to Dec 2010
- Phase
- Phase 3
- 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
- Diagnosis of adenocarcinoma of the pancreas
- Locally advanced or metastatic disease
- Measurable disease, defined as at least 1 lesion measurable by RECIST criteria
- WHO performance status 0-2
- Absolute neutrophil count > 1,500/mm^3
- Platelet count > 100,000/mm^3
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- Creatinine < 1.5 times normal
- Transaminases < 2 times normal (5 times normal if liver metastases)
- Total bilirubin < 1.5 times normal
- Fertile patients must use effective contraception
- See Disease Characteristics
- At least 6 months since prior chemotherapy or radiochemotherapy
- At least 4 weeks since prior radiotherapy and/or surgery
Who cannot join
- Brain metastases
- PATIENT CHARACTERISTICS:
- Pregnant or nursing
- Intestinal occlusion
- Prior inflammatory intestinal disease
- Crohn's disease
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- Hemorrhagic rectal colitis
- Peripheral neuropathy > grade 2
- Other severe illness, including any of the following:
- Unstable cardiac disease, even if treated
- Psychological or neurological disease including dementia
- Uncontrolled active infection
- Other severe illness that would compromise study participation
- Impossible to receive study therapy due to geographical, social, or psychological reasons
- Other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix
- PRIOR CONCURRENT THERAPY:
- Prior therapy for advanced disease
- Prior inhibitors of kinase signaling (e.g., ras/raf, MEK, AKT, mTOR, or farnesyl transferase)
- Prior inhibitors of angiogenesis (e.g., bevacizumab)
- Prior organ graft or allogeneic transplantation
- Prior extensive intestinal resection
- Concurrent participation in another therapeutic study
- Concurrent inductors of CYP3A4 (e.g., barbiturates, anti-epileptics, or rifampicin)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, 13273
Frederic Viret, MD, 33-4-91-22-35-37, viretf@marseille.fnclcc.fr
About this study
Official title: Phase III Randomized, Double-blind Study Comparing Gemcitabine and Sorafenib or a Placebo in Patients With Locally Advanced or Metastatic Cancer of the Pancreas.
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. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether giving gemcitabine together with sorafenib is more effective than giving gemcitabine alone in treating pancreatic cancer.
PURPOSE: This randomized phase III trial is studying giving gemcitabine together with sorafenib to see how well it works compared with giving gemcitabine alone in treating patients with locally advanced or metastatic pancreatic cancer.
Read the detailed description
OBJECTIVES:
Primary
- Compare progression-free survival.
Secondary
- Compare toxicities.
- Compare response rate.
- Compare overall survival.
- Evaluate clinical benefits.
- Compare quality of life.
- Identify biomarkers that predict therapeutic response.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral sorafenib tosylate twice daily and gemcitabine hydrochloride IV once weekly for 7 weeks followed by 1 week of rest (course1). For the next 2 courses, patients receive gemcitabine hydrochloride weekly for 3 weeks followed by 1 week of rest and sorafenib tosylate twice daily.
- Arm II: Patients receive oral placebo twice daily and gemcitabine hydrochloride as in arm I.
After completing 3 courses of therapy, patients in both arms who have stable or responding disease may continue to receive sorafenib tosylate or placebo in the absence of disease progression or unacceptable toxicity.
- Conditions
- Pancreatic Cancer
- Being tested
- gemcitabine hydrochloride, sorafenib tosylate
- Keywords
- stage III pancreatic cancer, stage IV pancreatic cancer, adenocarcinoma of the pancreas, recurrent pancreatic cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sorafenib tosylateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Secondary outcomes (6)
Toxicities
Response rate
Overall survival
Clinical benefits
Quality of life by QLQ-C30
Biomarkers of response
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2007 (estimated)
- Study startDec 2006
- Primary completionDec 2010 (estimated)
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.
- More trials run by Institut Paoli-CalmettesThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Investigators
- Frederic Viret, MD, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00541021
- Sponsor's protocol ID
- CDR0000564099
- Other IDs
- IPC-BAYPAN, INCA-RECF0426, IPC-2005-006
- Status last verified
- Jul 2009
- First submitted
- 5 Oct 2007
- Last updated
- 15 Dec 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomized, Double-blind Study Comparing Gemcitabine and Sorafenib or a Placebo in Patients With Locally Advanced or Metastatic Cancer of the Pancreas.
- ClinicalTrials.gov ID
- NCT00541021
- Acronym / sponsor ID
- CDR0000564099
- Conditions
- Pancreatic Cancer
- Keywords
- stage III pancreatic cancer, stage IV pancreatic cancer, adenocarcinoma of the pancreas, recurrent pancreatic cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Dec 2010 (estimated)
- First posted
- 8 Oct 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. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether giving gemcitabine together with sorafenib is more effective than giving gemcitabine alone in treating pancreatic cancer.
PURPOSE: This randomized phase III trial is studying giving gemcitabine together with sorafenib to see how well it works compared with giving gemcitabine alone in treating patients with locally advanced or metastatic pancreatic cancer.
Detailed description
OBJECTIVES:
Primary
- Compare progression-free survival.
Secondary
- Compare toxicities.
- Compare response rate.
- Compare overall survival.
- Evaluate clinical benefits.
- Compare quality of life.
- Identify biomarkers that predict therapeutic response.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral sorafenib tosylate twice daily and gemcitabine hydrochloride IV once weekly for 7 weeks followed by 1 week of rest (course1). For the next 2 courses, patients receive gemcitabine hydrochloride weekly for 3 weeks followed by 1 week of rest and sorafenib tosylate twice daily.
- Arm II: Patients receive oral placebo twice daily and gemcitabine hydrochloride as in arm I.
After completing 3 courses of therapy, patients in both arms who have stable or responding disease may continue to receive sorafenib tosylate or placebo in the absence of disease progression or unacceptable toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Diagnosis of adenocarcinoma of the pancreas
- Measurable disease, defined as at least 1 lesion measurable by RECIST criteria
- WHO performance status 0-2
- Absolute neutrophil count > 1,500/mm^3
- Platelet count > 100,000/mm^3
Key exclusion criteria (23 listed)
- Brain metastases
- Pregnant or nursing
- Intestinal occlusion
- Prior inflammatory intestinal disease
- Crohn's disease
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 hydrochloride | Drug | – |
| sorafenib tosylate | Drug | – |
Primary outcome
Progression-free survival
6 secondary outcomes
Toxicities
Response rate
Overall survival
Clinical benefits
Quality of life by QLQ-C30
Biomarkers of response
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2009.
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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.
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, France
Frederic Viret, MD
Institut Paoli-Calmettes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing gemcitabine hydrochloride and sorafenib tosylate in people with Pancreatic Cancer, run by Institut Paoli-Calmettes at 1 site in France.
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 13 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 15 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival. 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 15 Dec 2009.