Pancreatic CancerNCT00159471
Genes as Predictors of Response to Gemcitabine, Docetaxel, and Capecitabine (GTX) in Metastatic or Unresectable Pancreatic Cancer.
A study testing capecitabine, gemcitabine, docetaxel in people with Pancreatic Cancer, run by University of Southern California at 1 site in United States.
Trial summary
This is a study for patients with advanced pancreatic cancer, using the drugs gemcitabine, docetaxel and capecitabine. Gemcitabine is a drug that has been approved by the FDA. Gemcitabine is been approved for treatment of cancer of the pancreas. 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?
- capecitabine, gemcitabine, docetaxel
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to Jul 2006
- Phase
- Interventional
- 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
- Patients must have clinically documented unresectable or metastatic pancreatic cancer and histologic confirmation of the diagnosis with tumor.
- Tissue from tumor must be available. This may be paraffin embedded tissue from previous biopsy/resection or if it is not available, a repeat biopsy must be performed.
- Patients must agree to have a 20 cc blood sample drawn in addition to routine labs with each cycle of chemotherapy.
- Patients must have measurable disease by clinical exam or radiologic studies, that is at least one lesion measurable in at least one dimension, measuring 20mm. If prior radiation therapy was administered, measurable disease must be outside the radiation field.
- Patients may have received prior adjuvant chemotherapy and/or radiation therapy; this must have been completed at least 6 months prior to the initiation of therapy for metastatic disease.
- Patients must have a Zubrod performance status of 0-2.
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- Peripheral Neuropathy must be less than grade 1
- Patients must have a predicted life expectancy of at least 12 weeks.
- Patients must have a pre-treatment granulocyte count (i.e., segmented neutrophils + bands) of greater than 1,500/mm3, a hemoglobin level of greater than or equal to 9.0 gm/dl, and a platelet count of greater than 100,000/mm3.
- Patients must have adequate renal function as documented by a calculated creatinine clearance greater than 60.
- No major surgery within 1 month of starting study drug.
Who cannot join
- Patients who have received prior adjuvant therapy with more than one of the following agents: gemcitabine, docetaxel or capecitabine
- Patients who have received prior treatment for metastatic or unresectable pancreatic cancer.
- Patients may not have a history of an allergy to gemcitabine, taxanes or fluoropyrimidines and polysorbate 80.
- Patients with any active or uncontrolled infection, including known HIV infection.
- Patients with psychiatric disorders that would interfere with consent or follow-up.
- Patients with a history of myocardial infarction within the previous six months or congestive heart failure requiring therapy.
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- Pregnant or lactating women. Men and women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while on treatment and for at least 3 months thereafter.
- Presence of clinically apparent central nervous system metastases or carcinomatous meningitis
- Patients with a history of seizures are ineligible. Patients receiving phenytoin, phenobarbital, or other anti-epileptic prophylaxis are ineligible.
- Patients with any other severe concurrent disease, which in the judgment of the investigator would make the patient inappropriate for entry into this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
U.S.C / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: A Pilot Trial of Germline Polymorphisms as Predictors of Response to Gemcitabine, Docetaxel, and Capecitabine (GTX) in Metastatic or Unresectable Pancreatic Cancer.
This is a study for patients with advanced pancreatic cancer, using the drugs gemcitabine, docetaxel and capecitabine. Gemcitabine is a drug that has been approved by the FDA. Gemcitabine is been approved for treatment of cancer of the pancreas. It is also approved for treatment of lung cancer in combination with another drug called cisplatin. Docetaxel is a drug approved by the FDA. Docetaxel is approved for treatment of breast and lung cancer. Capecitabine is a drug approved by the FDA for treatment of cancer of the colon and rectum. This study will measure the levels of certain substances in participant's tumors. These substances (called genes, which are the cell's blueprint for these substances) affect how people's bodies react to the cancer drugs. Genes will also be measured in participant's blood. The purpose of this study is to see if these substances can predict survival and response in patients receiving the study drugs. In this study we wish to find out how long it takes for patients' cancers to worsen, and how long they survive after receiving the study drugs. The side effects of the combination of gemcitabine, docetaxel and capecitabine will also be evaluated.
- Conditions
- Pancreatic Cancer
- Being tested
- capecitabine, gemcitabine, 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.
capecitabine, gemcitabine, docetaxelDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To see if patients with advanced pancreatic cancer treated with gemcitabine, docetaxel and capecitabine who bear more favorable genotypes of genes involved in drug metabolisms are more likely to have response and survive longer than those that do not.
Secondary outcomes (1)
To assess time to progression, toxicity and to identify other molecular correlates of response, toxicity, and survival.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startFeb 2005
- Primary completionJun 2006
- Study completionJul 2006
Why it stopped: Insufficient Accrual
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 University of Southern CaliforniaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Syma Iqbal, M.D., Principal investigator, U.S.C. / Norris Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00159471
- Sponsor's protocol ID
- 3P-03-2
- Status last verified
- May 2014
- First submitted
- 9 Sep 2005
- Last updated
- 22 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Trial of Germline Polymorphisms as Predictors of Response to Gemcitabine, Docetaxel, and Capecitabine (GTX) in Metastatic or Unresectable Pancreatic Cancer.
- ClinicalTrials.gov ID
- NCT00159471
- Acronym / sponsor ID
- 3P-03-2
- Conditions
- Pancreatic Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient Accrual
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Feb 2005
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 12 Sep 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 is a study for patients with advanced pancreatic cancer, using the drugs gemcitabine, docetaxel and capecitabine. Gemcitabine is a drug that has been approved by the FDA. Gemcitabine is been approved for treatment of cancer of the pancreas. It is also approved for treatment of lung cancer in combination with another drug called cisplatin. Docetaxel is a drug approved by the FDA. Docetaxel is approved for treatment of breast and lung cancer. Capecitabine is a drug approved by the FDA for treatment of cancer of the colon and rectum. This study will measure the levels of certain substances in participant's tumors. These substances (called genes, which are the cell's blueprint for these substances) affect how people's bodies react to the cancer drugs. Genes will also be measured in participant's blood. The purpose of this study is to see if these substances can predict survival and response in patients receiving the study drugs. In this study we wish to find out how long it takes for patients' cancers to worsen, and how long they survive after receiving the study drugs. The side effects of the combination of gemcitabine, docetaxel and capecitabine will also be evaluated.
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 (11 listed)
- Patients must have clinically documented unresectable or metastatic pancreatic cancer and histologic confirmation of the diagnosis with tumor.
- Tissue from tumor must be available. This may be paraffin embedded tissue from previous biopsy/resection or if it is not available, a repeat biopsy must be performed.
- Patients must agree to have a 20 cc blood sample drawn in addition to routine labs with each cycle of chemotherapy.
- Patients must have measurable disease by clinical exam or radiologic studies, that is at least one lesion measurable in at least one dimension, measuring 20mm. If prior radiation therapy was administered, measurable disease must be outside the radiation field.
- Patients may have received prior adjuvant chemotherapy and/or radiation therapy; this must have been completed at least 6 months prior to the initiation of therapy for metastatic disease.
Key exclusion criteria (10 listed)
- Patients who have received prior adjuvant therapy with more than one of the following agents: gemcitabine, docetaxel or capecitabine
- Patients who have received prior treatment for metastatic or unresectable pancreatic cancer.
- Patients may not have a history of an allergy to gemcitabine, taxanes or fluoropyrimidines and polysorbate 80.
- Patients with any active or uncontrolled infection, including known HIV infection.
- Patients with psychiatric disorders that would interfere with consent or follow-up.
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, gemcitabine, docetaxel | Drug | – |
Primary outcome
To see if patients with advanced pancreatic cancer treated with gemcitabine, docetaxel and capecitabine who bear more favorable genotypes of genes involved in drug metabolisms are more likely to have response and survive longer than those that do not.
1 secondary outcome
To assess time to progression, toxicity and to identify other molecular correlates of response, toxicity, and survival.
Results and safety
The study was stopped early (reason given: Insufficient Accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2014.
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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.
Syma Iqbal, M.D. principal investigator
U.S.C. / Norris Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing capecitabine, gemcitabine, docetaxel in people with Pancreatic Cancer, run by University of Southern California at 1 site 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 11 inclusion and 10 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: stopped early, as of the sponsor's last update on 22 May 2014. 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 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.
Are results available for this study?
The study was stopped early (reason given: Insufficient Accrual). 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.
What does the primary outcome measure?
To see if patients with advanced pancreatic cancer treated with gemcitabine, docetaxel and capecitabine who bear more favorable genotypes of genes involved in drug metabolisms are more likely to have response and survive longer than those that do not.. 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 22 May 2014.