Metastatic Pancreatic CarcinomaPhase 2NCT00137761
Docetaxel in Combination With Iressa in Previously Treated Patients With Pancreatic Cancer
A Phase 2 study testing ZD 1839 and Docetaxel in people with Metastatic Pancreatic Carcinoma, run by Dana-Farber Cancer Institute at 3 sites in United States.
Trial summary
The purpose of this study is to find out what activity the combination of docetaxel and Iressa have against metastatic pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Pancreatic Carcinoma
- What is being tested?
- ZD 1839 and Docetaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 32 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2004to Mar 2009
- 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); histologic confirmation of either the primary or metastatic site.
- ECOG performance status of < 1
- > 4 weeks since completion of previous chemotherapy
- > 4 weeks since participation in any investigational drug study
- Peripheral neuropathy of grade < 1
- Patients must have failed a gemcitabine-containing regimen administered in the metastatic, adjuvant, or locally advanced setting.
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- Absolute neutrophil count (ANC) > 1,500/mm3
- Hemoglobin > 9.0gm/dl
- Platelets > 100,000/mm3
- Total bilirubin < 2.0mg/dl
- AST and alkaline phosphatase < 5 x upper limit of normal (ULN)
- Albumin > 2.5gm/dl
- CA 19-9 > 1.5 x ULN
Who cannot join
- Prior therapy with taxane or with epidermal growth factor receptor (EGFR) inhibitors
- More than one prior chemotherapy treatment
- Clinically significant cardiac disease
- Major surgery within 4 weeks of the start of study treatment
- Evidence of central nervous system (CNS) metastases or carcinomatous meningitis or history of uncontrolled seizures, central nervous system disorders.
- Uncontrolled serious medical or psychiatric illness
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- Pregnant or breast-feeding women
- Other active malignancy
- Inability to swallow tablets or evidence of a gastrointestinal malabsorption syndrome
- Known severe hypersensitivity to Iressa
- Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, or St. John's wort.
- History of severe hypersensitivity reaction to drugs formulated with polysorbate 80
- Any evidence of clinically active interstitial lung disease
- Ascites requiring paracentesis
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Massachusetts General Hospital
Boston, Massachusetts, 02115
About this study
Official title: A Phase II Study of Docetaxel in Combination With ZD 1839 (IRESSA) in Previously Treated Patients With Metastatic Pancreatic Cancer
The purpose of this study is to find out what activity the combination of docetaxel and Iressa have against metastatic pancreatic cancer.
Read the detailed description
Iressa will be taken orally once daily without interruption. Docetaxel will be administered intravenously once weekly for two out of every three weeks. Patients will also receive dexamethasone the night prior, morning of, and the evening after docetaxel treatment to help prevent an allergic reaction.
Every week that chemotherapy is given, blood tests and vital signs will be taken.
After the first 6 weeks of therapy a CT scan (or other radiological procedure) will be done to assess the progress of the disease. If the cancer is responding to the treatment and no unacceptable side effects have occured, treatment with Iressa and docetaxel will continue.
CT scans (or other radiological procedure) will be performed at week 12 and every 9 weeks thereafter to monitor the progress of the disease.
- Conditions
- Metastatic Pancreatic Carcinoma
- Being tested
- ZD 1839, Docetaxel
- Keywords
- Pancreatic Carcinoma, Iressa, Docetaxel
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZD 1839Drug
Also called Iressa
Taken orally once daily
DocetaxelDrug
Given intravenously once weekly for 2 out of 3 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the response rate of Iressa and docetaxel in patients with advanced pancreatic cancer following failure of gemcitabine-based therapy
Measured: 3 years
Secondary outcomes (1)
To determine the safety, radiologic response rate, progression-free survival and overall survival of patients treated with Iressa and docetaxel
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2005 (estimated)
- Study startOct 2004
- Primary completionJun 2007
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Pancreatic CarcinomaStudies 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
- Massachusetts General Hospital, Beth Israel Deaconess Medical Center, Brigham and Women's Hospital
- Investigators
- Matthew Kulke, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00137761
- Sponsor's protocol ID
- 04-173
- Status last verified
- Oct 2009
- First submitted
- 26 Aug 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 Docetaxel in Combination With ZD 1839 (IRESSA) in Previously Treated Patients With Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00137761
- Acronym / sponsor ID
- 04-173
- Conditions
- Metastatic Pancreatic Carcinoma
- Keywords
- Pancreatic Carcinoma, Iressa, Docetaxel
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, Beth Israel Deaconess Medical Center, Brigham and Women's Hospital
- Study start
- Oct 2004
- Primary completion
- Jun 2007 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 30 Aug 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.
The purpose of this study is to find out what activity the combination of docetaxel and Iressa have against metastatic pancreatic cancer.
Detailed description
Iressa will be taken orally once daily without interruption. Docetaxel will be administered intravenously once weekly for two out of every three weeks. Patients will also receive dexamethasone the night prior, morning of, and the evening after docetaxel treatment to help prevent an allergic reaction.
Every week that chemotherapy is given, blood tests and vital signs will be taken.
After the first 6 weeks of therapy a CT scan (or other radiological procedure) will be done to assess the progress of the disease. If the cancer is responding to the treatment and no unacceptable side effects have occured, treatment with Iressa and docetaxel will continue.
CT scans (or other radiological procedure) will be performed at week 12 and every 9 weeks thereafter to monitor the progress of the disease.
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); histologic confirmation of either the primary or metastatic site.
- ECOG performance status of < 1
- > 4 weeks since completion of previous chemotherapy
- > 4 weeks since participation in any investigational drug study
- Peripheral neuropathy of grade < 1
Key exclusion criteria (14 listed)
- Prior therapy with taxane or with epidermal growth factor receptor (EGFR) inhibitors
- More than one prior chemotherapy treatment
- Clinically significant cardiac disease
- Major surgery within 4 weeks of the start of study treatment
- Evidence of central nervous system (CNS) metastases or carcinomatous meningitis or history of uncontrolled seizures, central nervous system disorders.
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 |
|---|---|---|
| ZD 1839Also: IressaTaken orally once daily | Drug | – |
| DocetaxelGiven intravenously once weekly for 2 out of 3 weeks | Drug | – |
Primary outcome
To determine the response rate of Iressa and docetaxel in patients with advanced pancreatic cancer following failure of gemcitabine-based therapy
Time frame: 3 years
1 secondary outcome
To determine the safety, radiologic response rate, progression-free survival and overall survival of patients treated with Iressa and docetaxel
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 ZD 1839 and Docetaxel in people with Metastatic Pancreatic Carcinoma, 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 14 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 determine the response rate of Iressa and docetaxel in patients with advanced pancreatic cancer following failure of gemcitabine-based therapy (time frame: 3 years). 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.