Pancreatic CancerPhase 2NCT00006117
Gemcitabine and Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
A Phase 2 study testing gemcitabine hydrochloride and oxaliplatin in people with Pancreatic Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 10 sites in 2 countries.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of gemcitabine and oxaliplatin in treating patients who have locally advanced or metastatic… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- gemcitabine hydrochloride and oxaliplatin
- How many people
- Not given
- Where
- 10 sitesin 2 countries
- Study dates
- Sep 1999to not given
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed metastatic or locally advanced unresectable adenocarcinoma of the pancreas Measurable disease At least 2 cm in diameter No known brain metastases
PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: ECOG 0-2 OR Karnofsky 60-100% Life expectancy: Greater than 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 5 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: Adequate cardiac function Pulmonary: Adequate respiratory function Other: Not pregnant or nursing Fertile patients must use effective contraception No sensitive neuropathy No other active malignancy No uncontrolled hypercalcemia No significant medical or psychiatric condition that would preclude study No psychological, familial, sociological, or geographical condition that would preclude study
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy Chemotherapy: No prior chemotherapy Endocrine therapy: No concurrent corticosteroid use except as antiemetic Radiotherapy: No prior radiotherapy Surgery: Not specified Other: No other concurrent investigational drugs
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
France9 sites
Centre Paul Papin
Angers, 49036
Centre Hospitalier Victor Dupouy
Argenteuil, 95107
Hopital Beaujon
Clichy, 92118
Hopital Drevon
Dijon, 21000
Clinique Saint Jean
Lyon, 69008
American Hospital of Paris
Neuilly-sur-Seine, F-92202
Hopital Saint Antoine
Paris, 75571
Hopital Tenon
Paris, 75970
Polyclinique De Courlancy
Reims, F-51100
About this study
Official title: Phase II Study of Gemcitabine Plus Oxaliplatin in Patients With Locally Advanced or Metastatic Pancreatic Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of gemcitabine and oxaliplatin in treating patients who have locally advanced or metastatic pancreatic cancer.
Read the detailed description
OBJECTIVES: I. Determine the objective tumor response rate in patients with locally advanced or metastatic pancreatic carcinoma when treated with gemcitabine and oxaliplatin. II. Determine the tolerablility and clinical benefit of this regimen in these patients. III. Evaluate the progression free survival and the overall survival of these patients when treated with this regimen.
OUTLINE: This is a multicenter study. Patients receive gemcitabine IV on day 1 over 1.5 hours and oxaliplatin IV over 2 hours on day 2. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity. Patients with locally advanced disease receive 6-8 courses and then may undergo surgery, radiotherapy, and/or additional chemotherapy.
PROJECTED ACCRUAL: A total of 66 patients will be accrued for this study.
- Conditions
- Pancreatic Cancer
- Being tested
- gemcitabine hydrochloride, oxaliplatin
- Keywords
- stage III pancreatic cancer, stage IV 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2004 (estimated)
- Study startSep 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
Sponsor and investigators
- Lead sponsor
- GERCOR - Multidisciplinary Oncology Cooperative Group
- Sponsor type
- University, hospital or other
- Investigators
- Christophe Louvet, MD, PhD, Study chair, Hopital Saint Antoine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006117
- Sponsor's protocol ID
- CDR0000068130
- Other IDs
- FRE-GERCOR-GEMOX-D99-2, EU-20027
- Status last verified
- Oct 2009
- First submitted
- 3 Aug 2000
- Last updated
- 30 Oct 2009
- Results posted
- No
Publications
Huguet F, Andre T, Hammel P, Artru P, Balosso J, Selle F, Deniaud-Alexandre E, Ruszniewski P, Touboul E, Labianca R, de Gramont A, Louvet C. Impact of chemoradiotherapy after disease control with chemotherapy in locally advanced pancreatic adenocarcinoma in GERCOR phase II and III studies. J Clin Oncol. 2007 Jan 20;25(3):326-31. doi: 10.1200/JCO.2006.07.5663.
PubMed 17235048Afchain P, Chibaudel B, Lledo G, Selle F, Bengrine-Lefevre L, Nguyen S, Paitel JF, Mineur L, Artru P, Andre T, Louvet C. First-line simplified GEMOX (S-GemOx) versus classical GEMOX in metastatic pancreatic cancer (MPA): results of a GERCOR randomized phase II study. Bull Cancer. 2009 May;96(5):E18-22. doi: 10.1684/bdc.2009.0871. Epub 2009 May 12.
PubMed 19435690Louvet C, Andre T, Lledo G, Hammel P, Bleiberg H, Bouleuc C, Gamelin E, Flesch M, Cvitkovic E, de Gramont A. Gemcitabine combined with oxaliplatin in advanced pancreatic adenocarcinoma: final results of a GERCOR multicenter phase II study. J Clin Oncol. 2002 Mar 15;20(6):1512-8. doi: 10.1200/JCO.2002.20.6.1512.
PubMed 11896099
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Gemcitabine Plus Oxaliplatin in Patients With Locally Advanced or Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00006117
- Acronym / sponsor ID
- CDR0000068130
- Conditions
- Pancreatic Cancer
- Keywords
- stage III pancreatic cancer, stage IV pancreatic cancer, adenocarcinoma of the pancreas
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- GERCOR - Multidisciplinary Oncology Cooperative GroupUniversity, hospital or other
- Study start
- Sep 1999
- First posted
- 22 Jun 2004 (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 use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of gemcitabine and oxaliplatin in treating patients who have locally advanced or metastatic pancreatic cancer.
Detailed description
OBJECTIVES: I. Determine the objective tumor response rate in patients with locally advanced or metastatic pancreatic carcinoma when treated with gemcitabine and oxaliplatin. II. Determine the tolerablility and clinical benefit of this regimen in these patients. III. Evaluate the progression free survival and the overall survival of these patients when treated with this regimen.
OUTLINE: This is a multicenter study. Patients receive gemcitabine IV on day 1 over 1.5 hours and oxaliplatin IV over 2 hours on day 2. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity. Patients with locally advanced disease receive 6-8 courses and then may undergo surgery, radiotherapy, and/or additional chemotherapy.
PROJECTED ACCRUAL: A total of 66 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 | – |
| oxaliplatin | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2009.
- Background: PubMed 17235048Huguet F, Andre T, Hammel P, Artru P, Balosso J, Selle F, Deniaud-Alexandre E, Ruszniewski P, Touboul E, Labianca R, de Gramont A, Louvet C. Impact of chemoradiotherapy after disease control with chemotherapy in locally advanced pancreatic adenocarcinoma in GERCOR phase II and III studies. J Clin Oncol. 2007 Jan 20;25(3):326-31. doi: 10.1200/JCO.2006.07.5663.
- Results publication: PubMed 19435690Afchain P, Chibaudel B, Lledo G, Selle F, Bengrine-Lefevre L, Nguyen S, Paitel JF, Mineur L, Artru P, Andre T, Louvet C. First-line simplified GEMOX (S-GemOx) versus classical GEMOX in metastatic pancreatic cancer (MPA): results of a GERCOR randomized phase II study. Bull Cancer. 2009 May;96(5):E18-22. doi: 10.1684/bdc.2009.0871. Epub 2009 May 12.
- Results publication: PubMed 11896099Louvet C, Andre T, Lledo G, Hammel P, Bleiberg H, Bouleuc C, Gamelin E, Flesch M, Cvitkovic E, de Gramont A. Gemcitabine combined with oxaliplatin in advanced pancreatic adenocarcinoma: final results of a GERCOR multicenter phase II study. J Clin Oncol. 2002 Mar 15;20(6):1512-8. doi: 10.1200/JCO.2002.20.6.1512.
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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.
Christophe Louvet, MD, PhD study chair
Hopital Saint Antoine
10 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 hydrochloride and oxaliplatin in people with Pancreatic Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 10 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?
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 30 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France, Belgium. 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?
Results are not available in the source record.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00006117, which also lists 3 linked publications.
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 30 Oct 2009.