Pancreatic CancerPhase 2NCT00125021
Tarceva and Capecitabine for Pancreatic Cancer
A Phase 2 study testing Capecitabine and OSI-774 in people with Pancreatic Cancer and Neoplasm Metastasis, run by Dana-Farber Cancer Institute at 3 sites in United States.
Trial summary
This phase II trial is designed to investigate the effectiveness of Tarceva (OSI-774) combined with capecitabine in treating patients with metastatic pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Neoplasm Metastasis
- What is being tested?
- Capecitabine and OSI-774
- How many people
- 32 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2003to Sep 2008
- 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
- Metastatic pancreatic carcinoma (excluding pancreatic endocrine tumors)
- Only patients with measurable disease
- ECOG performance status < or equal to 1
- Life expectancy >12 weeks
- Signed informed consent
- Failed or intolerance to first-line therapy for metastatic disease with a gemcitabine-containing regimen. Patients may have received adjuvant therapy in addition to one prior regimen for metastatic disease.
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- >4 weeks must have elapsed from the completion of previous chemotherapy and patients must have recovered from any related toxicities
- >4 weeks must have elapsed from the participation in any investigational drug study
- Laboratory values:
- ANC > 1500/mm3;
- Hemoglobin > 9.0 gm/dl;
- Platelets > 100,000/mm3;
- SGOT <2.5 X upper limit of normal; or <5 X upper limit of normal if evidence of liver metastases; Alkaline phosphatase < 2.5 X upper limit of normal; or < 5 X upper limit of normal if evidence of liver metastases; Total bilirubin < 1.5 X upper limit of normal; Creatinine clearance > 50 cc/min (by Cockroft - Gault or as determined from a 24-hour urine collection).
Who cannot join
- Prior therapy with capecitabine or epidermal growth factor receptor (EGFR) inhibitors
- More than one prior chemotherapy treatment regimen for metastatic disease
- Clinically apparent central nervous system (CNS) metastases or carcinomatous meningitis
- Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication or heart attack within the last 12 months).
- Major surgery within 4 weeks of the start of study treatment, without complete recovery.
- Evidence of CNS metastases (unless CNS metastases have been stable for > 3 months) or history of uncontrolled seizures, central nervous system disorders
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- Uncontrolled serious medical or psychiatric illness
- Women must not be pregnant or lactating
- Concurrent radiation therapy
- Other active malignancy
- Inability to swallow tablets
- Patients lacking physical integrity of the upper gastrointestinal tract or who have malabsorption syndrome
- Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: A Phase II Study of OSI-774 (Tarceva) in Combination With Capecitabine in Previously Treated Patients With Metastatic Pancreatic Cancer
This phase II trial is designed to investigate the effectiveness of Tarceva (OSI-774) combined with capecitabine in treating patients with metastatic pancreatic cancer.
Read the detailed description
Patients will be treated once daily with Tarceva, twice daily with capecitabine for 14 consecutive days, followed by 7 days off of capecitabine (a cycle is 21 days). At week 1 of each cycle a physical exam and blood work will be performed. Reassessment of tumor size will be conducted at 6 weeks (2 cycles), 12 weeks (4 cycles) and then every 9 weeks thereafter. Patients will remain on treatment until one of the following occur: disease progression, illness that prevents further treatment or unacceptable adverse events.
- Conditions
- Pancreatic Cancer, Neoplasm Metastasis
- Being tested
- Capecitabine, OSI-774
- Keywords
- Second Line Therapy, Gemcitabine Refractory, Pancreatic Cancer, Capecitabine, Tarceva, OSI-774, Metastatic Pancreatic Cancer
- Medical subject headings
- Pancreatic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
Given twice a day for 14 days followed by 7 days of no capecitabine (1 cycle is 21 days).
OSI-774Drug
Also called Tarceva
Given once daily
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the response rate associated with capecitabine and OSI-774 in patients with advanced pancreatic cancer
Secondary outcomes (2)
To assess the side effects of capecitabine and OSI-774 in patients with advanced pancreatic cancer
Measured: 2 years
to estimate the time to progression and overall survival of patients with advanced pancreatic cancer treated with capecitabine and OSI-774
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2005 (estimated)
- Study startOct 2003
- Primary completionJun 2004
- Study completionSep 2008
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 Dana-Farber Cancer InstituteThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc., Roche Global Development, Brigham and Women's Hospital, Massachusetts General Hospital, Beth Israel Deaconess Medical Center
- Investigators
- Matthew Kulke, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00125021
- Sponsor's protocol ID
- 03-070
- Status last verified
- Oct 2009
- First submitted
- 27 Jul 2005
- Last updated
- 2 Nov 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of OSI-774 (Tarceva) in Combination With Capecitabine in Previously Treated Patients With Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00125021
- Acronym / sponsor ID
- 03-070
- Conditions
- Pancreatic Cancer, Neoplasm Metastasis
- Keywords
- Second Line Therapy, Gemcitabine Refractory, Pancreatic Cancer, Capecitabine, Tarceva, OSI-774, Metastatic Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Genentech, Inc., Roche Global Development, Brigham and Women's Hospital, Massachusetts General Hospital, Beth Israel Deaconess Medical Center
- Study start
- Oct 2003
- Primary completion
- Jun 2004 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 29 Jul 2005 (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.
This phase II trial is designed to investigate the effectiveness of Tarceva (OSI-774) combined with capecitabine in treating patients with metastatic pancreatic cancer.
Detailed description
Patients will be treated once daily with Tarceva, twice daily with capecitabine for 14 consecutive days, followed by 7 days off of capecitabine (a cycle is 21 days). At week 1 of each cycle a physical exam and blood work will be performed. Reassessment of tumor size will be conducted at 6 weeks (2 cycles), 12 weeks (4 cycles) and then every 9 weeks thereafter. Patients will remain on treatment until one of the following occur: disease progression, illness that prevents further treatment or unacceptable adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Metastatic pancreatic carcinoma (excluding pancreatic endocrine tumors)
- Only patients with measurable disease
- ECOG performance status < or equal to 1
- Life expectancy >12 weeks
- Signed informed consent
Key exclusion criteria (13 listed)
- Prior therapy with capecitabine or epidermal growth factor receptor (EGFR) inhibitors
- More than one prior chemotherapy treatment regimen for metastatic disease
- Clinically apparent central nervous system (CNS) metastases or carcinomatous meningitis
- Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication or heart attack within the last 12 months).
- Major surgery within 4 weeks of the start of study treatment, without complete recovery.
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 |
|---|---|---|
| CapecitabineGiven twice a day for 14 days followed by 7 days of no capecitabine (1 cycle is 21 days). | Drug | – |
| OSI-774Also: TarcevaGiven once daily | Drug | – |
Primary outcome
To assess the response rate associated with capecitabine and OSI-774 in patients with advanced pancreatic cancer
2 secondary outcomes
To assess the side effects of capecitabine and OSI-774 in patients with advanced pancreatic cancer
Time frame: 2 years
to estimate the time to progression and overall survival of patients with advanced pancreatic cancer treated with capecitabine and OSI-774
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 2 Nov 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.
Matthew Kulke, MD principal investigator
Dana-Farber Cancer Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Capecitabine and OSI-774 in people with Pancreatic Cancer and Neoplasm Metastasis, run by Dana-Farber Cancer Institute at 3 sites in United States.
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 13 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 2 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
To assess the response rate associated with capecitabine and OSI-774 in patients with advanced pancreatic cancer. 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 2 Nov 2009.