Adenocarincoma of PancreasPhase 2NCT00323583
Weekly Dosing of an Integrative Chemotherapy Combination to Treat Advanced Pancreatic Cancer
A Phase 2 study testing paclitaxel, oxaliplatin and leucovorin in people with Adenocarincoma of Pancreas and Stage III Pancreatic Cancer, run by Seattle Cancer Treatment and Wellness Center at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, oxaliplatin, leucovorin and 5-fluoruracil, work in different ways separately and in combination to stop tumor cells from dividing so they stop growing or die. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Adenocarincoma of Pancreas, Stage III Pancreatic Cancer, Stage IVA Pancreatic Cancer
- What is being tested?
- paclitaxel, oxaliplatin and leucovorin
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Performance state >=3
- Uncontrolled serious concomitant disease
- Radiotherapy within the 6 weeks before Cycle 1' Day 1
- Surgery within the 2 weeks before Cycle 1' Day 1
Trial locations and contacts
1 site in 1 country.
Ben Chue, MD contact
United States1 site, 1 recruiting
- Recruiting
Seattle Cancer Treatment and Wellness Center
Seattle, Washington, 98112
Nick Chen, MD, 206-292-2277, nickc@seattlecancerwellness.com
Jerry Kaufman, 206-292-2277, jerryk@seattelcancerwellness.com
About this study
Official title: Phase II Study of Paclitaxel, Oxaliplatin, Leucovorin and 5-Fluorouracil (POLF) in Gemcitabine-Refractory Advanced Pancreatic Cancer
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, oxaliplatin, leucovorin and 5-fluoruracil, work in different ways separately and in combination to stop tumor cells from dividing so they stop growing or die. The use of metronomic dosing of chemotherapy minimizes side effects and increases efficacy by anti-angiogenic effects. The pilot study demonstrated promising responses in all patients. It is not yet known how effective this drug and dosing combination is in treating advanced pancreatic cancer.
PURPOSE: This non-randomized phase II trial is studying giving weekly doses of paclitaxel, oxaliplatin, leucovorin and 5-fluorouracil together as second or third-line therapy in treating patient with locally advanced unresectable or metastatic adenocarcinoma of the pancreas following demonstrated progression after first-line gemcitabine.
Read the detailed description
OBJECTIVES:
- The primary objective is to determine the effectiveness the chemotherapy combination in improving the experience of those with advanced pancreatic cancer in
- Pain control and other aspects of quality of life
- Reduction of the tumor size or stabilization of tumor growth
- Progression free survival
- Overall survival
- The secondary objective is to determine the safety of this chemotherapy combination by monitoring and the managing the potential side effects
DOSE REGIMEN OUTLINE: Paclitaxel 60mg/m2 IV weekly; Oxaliplatin 50mg/m2 IV weekly; Leucovorin 20 mg/m2 IV weekly, minimum of 40 mg; 5FU 425mg/m2 IV weekly; Weekly for 12 weeks; Calcium and magnesium 1gram each IV prior to and after Oxaliplatin therapy; Glutathione 1500mg/m2 prior to Oxaliplatin
DURATION OF STUDY PERIOD: Patient will continue study treatment until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay greater than 3 weeks, 12 weeks initially, can than continue at discretion of investigator.
EXPECTED NUMBER OF PATIENTS: A total of 80 patients (40 second line of treatment and 40 third line or greater of treatment) will be enrolled for this study beginning in May 2006.
QUALITY OF LIFE: Quality of life will be assessed at baseline, each month of treatment and at the end of study therapy.
- Conditions
- Adenocarincoma of Pancreas, Stage III Pancreatic Cancer, Stage IVA Pancreatic Cancer, Stage IVB Pancreatic Cancer
- Being tested
- paclitaxel, oxaliplatin, leucovorin, 5-fluorouracil, glutathione
- Keywords
- Cancer, Pancreatic Cancer, Cancer Alternative Therapies, Living with Cancer
- Medical subject headings
- Pancreatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paclitaxelDrug
oxaliplatinDrug
leucovorinDrug
5-fluorouracilDrug
glutathioneDrug
calcium and magnesiumDrug
ChemotherapyProcedure or surgery
ChemoprotectionProcedure or surgery
Complementary and alternative therapyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response rate (PS improvement by ECOG score, analgesic dose reduction)
Response Rate Recist (Uni-Dimensional) Criteria
Progression free survival
Median survival
Overall survival
Quality of life
Secondary outcomes (1)
Tolerance and Safety NCI-CTC version 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2006 (estimated)
- Study startMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarincoma of PancreasStudies 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seattle Cancer Treatment and Wellness Center
- Sponsor type
- University, hospital or other
- Investigators
- Ben Chue, MD, Principal investigator, Seattle Cancer Treatment and Wellness Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00323583
- Sponsor's protocol ID
- CTCA06-02
- Status last verified
- May 2007
- First submitted
- 5 May 2006
- Last updated
- 8 May 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Paclitaxel, Oxaliplatin, Leucovorin and 5-Fluorouracil (POLF) in Gemcitabine-Refractory Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00323583
- Acronym / sponsor ID
- CTCA06-02
- Conditions
- Adenocarincoma of Pancreas, Stage III Pancreatic Cancer, Stage IVA Pancreatic Cancer, Stage IVB Pancreatic Cancer
- Keywords
- Cancer, Pancreatic Cancer, Cancer Alternative Therapies, Living with Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Seattle Cancer Treatment and Wellness CenterUniversity, hospital or other
- Study start
- May 2006
- First posted
- 9 May 2006 (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 paclitaxel, oxaliplatin, leucovorin and 5-fluoruracil, work in different ways separately and in combination to stop tumor cells from dividing so they stop growing or die. The use of metronomic dosing of chemotherapy minimizes side effects and increases efficacy by anti-angiogenic effects. The pilot study demonstrated promising responses in all patients. It is not yet known how effective this drug and dosing combination is in treating advanced pancreatic cancer.
PURPOSE: This non-randomized phase II trial is studying giving weekly doses of paclitaxel, oxaliplatin, leucovorin and 5-fluorouracil together as second or third-line therapy in treating patient with locally advanced unresectable or metastatic adenocarcinoma of the pancreas following demonstrated progression after first-line gemcitabine.
Detailed description
OBJECTIVES:
- The primary objective is to determine the effectiveness the chemotherapy combination in improving the experience of those with advanced pancreatic cancer in
- Pain control and other aspects of quality of life
- Reduction of the tumor size or stabilization of tumor growth
- Progression free survival
- Overall survival
- The secondary objective is to determine the safety of this chemotherapy combination by monitoring and the managing the potential side effects
DOSE REGIMEN OUTLINE: Paclitaxel 60mg/m2 IV weekly; Oxaliplatin 50mg/m2 IV weekly; Leucovorin 20 mg/m2 IV weekly, minimum of 40 mg; 5FU 425mg/m2 IV weekly; Weekly for 12 weeks; Calcium and magnesium 1gram each IV prior to and after Oxaliplatin therapy; Glutathione 1500mg/m2 prior to Oxaliplatin
DURATION OF STUDY PERIOD: Patient will continue study treatment until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay greater than 3 weeks, 12 weeks initially, can than continue at discretion of investigator.
EXPECTED NUMBER OF PATIENTS: A total of 80 patients (40 second line of treatment and 40 third line or greater of treatment) will be enrolled for this study beginning in May 2006.
QUALITY OF LIFE: Quality of life will be assessed at baseline, each month of treatment and at the end of study therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- Performance state >=3
- Uncontrolled serious concomitant disease
- Radiotherapy within the 6 weeks before Cycle 1' Day 1
- Surgery within the 2 weeks before Cycle 1' Day 1
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 |
|---|---|---|
| paclitaxel | Drug | – |
| oxaliplatin | Drug | – |
| leucovorin | Drug | – |
| 5-fluorouracil | Drug | – |
| glutathione | Drug | – |
| calcium and magnesium | Drug | – |
| Chemotherapy | Procedure or surgery | – |
| Chemoprotection | Procedure or surgery | – |
| Complementary and alternative therapy | Procedure or surgery | – |
Primary outcome
Clinical response rate (PS improvement by ECOG score, analgesic dose reduction)
Response Rate Recist (Uni-Dimensional) Criteria
Progression free survival
Median survival
Overall survival
Quality of life
1 secondary outcome
Tolerance and Safety NCI-CTC version 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2007.
- Seattle Cancer Treatment and Wellness CenterLink provided by the sponsor.
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.
Ben Chue, MD contact
Ben Chue, MD principal investigator
Seattle Cancer Treatment and Wellness Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing paclitaxel, oxaliplatin and leucovorin in people with Adenocarincoma of Pancreas and Stage III Pancreatic Cancer, run by Seattle Cancer Treatment and Wellness Center 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 0 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 8 May 2007. 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.
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?
Contact Ben Chue, MD (206-292-2277), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical response rate (PS improvement by ECOG score, analgesic dose reduction). The study lists 6 primary outcomes in all. 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 8 May 2007.