Pancreatic CancerPhase 1NCT00885066
Gemcitabine, Capecitabine, and Erlotinib in Treating Patients With Advanced Pancreatic Cancer
A Phase 1 study testing capecitabine, erlotinib hydrochloride and gemcitabine hydrochloride in people with Pancreatic Cancer, run by Centre Antoine Lacassagne at 1 site in France.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib 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 to 75 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- capecitabine, erlotinib hydrochloride and gemcitabine hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- May 2008to Oct 2009
- Phase
- Phase 1
- 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 adenocarcinoma of the pancreas
- Advanced disease
- No standard curative therapy available
- Must have received prior first-line chemotherapy
- No brain metastasis
PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- Life expectancy ≥ 8 weeks
- ANC ≥ 1.5 x 10^9/ L
- Platelet count ≥ 130 x 10^9/ L
- Hemoglobin ≥ 10 g/dL
- Liver transaminases ≤ 1.5 times upper limit of normal (ULN) (≤ 5 times ULN in the presence of liver metastases)
- Bilirubin ≤ 1.5 times ULN
- Creatinine ≤ 130 mmol/L OR creatinine clearance > 30 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No intolerance or hypersensitivity to any of the drugs being tested
- No history of interstitial lung disease
- No history of severe cardiac disease
- No serious uncontrolled infection
- No rare hereditary disorders, i.e., galactosemia, lactase deficiency, or malabsorption of glucose or galactose syndrome
- Must not be deprived of liberty or under guardianship
- Must not be on probation
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior erlotinib hydrochloride
- No concurrent potent inducers or inhibitors of cytochrome P450 or CYP3A4
- More than 14 days since participation in another clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Study of Gemcitabine, Capecitabine, and Erlotinib Together in Advanced Pancreatic Cancers
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of gemcitabine given together with capecitabine and erlotinib in treating patients with advanced pancreatic cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the maximum-tolerated dose of the combination of gemcitabine hydrochloride, capecitabine, and erlotinib hydrochloride in patients with advanced pancreatic cancer.
Secondary
- Analyze the limiting toxicities according to CTC.
- Analyze the toxicity according to CTC.
- Determine the recommended dose.
- Determine the pharmacokinetic dosages of the three drugs.
- Analyze interactions between the drugs.
OUTLINE: This is a multicenter study.
Patients receive one course of chemotherapy comprising gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15, oral capecitabine twice daily on days 1-21, and oral erlotinib hydrochloride once daily on days 1-28.
- Conditions
- Pancreatic Cancer
- Being tested
- capecitabine, erlotinib hydrochloride, gemcitabine hydrochloride
- 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.
capecitabineDrug
erlotinib hydrochlorideDrug
| Study group | Role | What they receive |
|---|---|---|
| gemcitabine, capecitabine, erlotinib | Experimental | Not described Receives: Drug: capecitabine; Drug: erlotinib hydrochloride; Drug: gemcitabine hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical or laboratory toxicities as assessed by CTC
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2009 (estimated)
- Study startMay 2008
- Primary completionSep 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Antoine Lacassagne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Francois, Principal investigator, Centre Antoine Lacassagne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00885066
- Sponsor's protocol ID
- 2007/36
- Other IDs
- CALACASS-CAPERGEM, ROCHE-CALACASS-CAPERGEM, INCA-RECF0622, 2007-005072-14
- Status last verified
- Apr 2026
- First submitted
- 18 Apr 2009
- Last updated
- 23 Apr 2026
- Results posted
- No
Publications
Francois E, Bennouna J, Chamorey E, Etienne-Grimaldi MC, Renee N, Senellart H, Michel C, Follana P, Mari V, Douillard JY, Milano G. Phase I trial of gemcitabine combined with capecitabine and erlotinib in advanced pancreatic cancer: a clinical and pharmacological study. Chemotherapy. 2012;58(5):371-80. doi: 10.1159/000343969. Epub 2012 Dec 11.
PubMed 23235319
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Gemcitabine, Capecitabine, and Erlotinib Together in Advanced Pancreatic Cancers
- ClinicalTrials.gov ID
- NCT00885066
- Acronym / sponsor ID
- 2007/36
- Conditions
- Pancreatic Cancer
- Keywords
- stage III pancreatic cancer, stage IV pancreatic cancer, adenocarcinoma of the pancreas, recurrent pancreatic cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Antoine LacassagneUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 21 Apr 2009 (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 and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of gemcitabine given together with capecitabine and erlotinib in treating patients with advanced pancreatic cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the maximum-tolerated dose of the combination of gemcitabine hydrochloride, capecitabine, and erlotinib hydrochloride in patients with advanced pancreatic cancer.
Secondary
- Analyze the limiting toxicities according to CTC.
- Analyze the toxicity according to CTC.
- Determine the recommended dose.
- Determine the pharmacokinetic dosages of the three drugs.
- Analyze interactions between the drugs.
OUTLINE: This is a multicenter study.
Patients receive one course of chemotherapy comprising gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15, oral capecitabine twice daily on days 1-21, and oral erlotinib hydrochloride once daily on days 1-28.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| gemcitabine, capecitabine, erlotinib | Experimental | Drug: capecitabine, Drug: erlotinib hydrochloride, Drug: gemcitabine hydrochloride |
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 |
|---|---|---|
| capecitabine | Drug | gemcitabine, capecitabine, erlotinib |
| erlotinib hydrochloride | Drug | gemcitabine, capecitabine, erlotinib |
| gemcitabine hydrochloride | Drug | gemcitabine, capecitabine, erlotinib |
Primary outcome
Clinical or laboratory toxicities as assessed by CTC
Time frame: 1 year
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 23 Apr 2026.
- Results publication: PubMed 23235319Francois E, Bennouna J, Chamorey E, Etienne-Grimaldi MC, Renee N, Senellart H, Michel C, Follana P, Mari V, Douillard JY, Milano G. Phase I trial of gemcitabine combined with capecitabine and erlotinib in advanced pancreatic cancer: a clinical and pharmacological study. Chemotherapy. 2012;58(5):371-80. doi: 10.1159/000343969. Epub 2012 Dec 11.
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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.
Eric Francois principal investigator
Centre Antoine Lacassagne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing capecitabine, erlotinib hydrochloride and gemcitabine hydrochloride in people with Pancreatic Cancer, run by Centre Antoine Lacassagne 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?
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 23 Apr 2026. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Clinical or laboratory toxicities as assessed by CTC (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00885066, which also lists 1 linked publication.
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 23 Apr 2026.