Pancreatic NeoplasmsPhase 1NCT00220649
Safety Study of Combination Chemotherapy in Patients With Metastatic Solid Tumors or Adenocarcinoma of the Pancreas
A Phase 1 study testing gemcitabine; irinotecan; leucovorin; 5-fluorouracil; oxaliplatin in people with Pancreatic Neoplasms, run by St. Luke's-Roosevelt Hospital Center at 1 site in United States.
Trial summary
The purpose of this trial is to determine the maximum tolerated dose and the dose-limiting toxicity of biweekly oxaliplatin in combination with fixed doses of irinotecan, 5-fluorouracil/leucovorin and gemcitabine in patients with metastatic solid tumors or adenocarcinoma of the pancreas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Neoplasms
- What is being tested?
- gemcitabine; irinotecan; leucovorin; 5-fluorouracil; oxaliplatin
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to not given
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed diagnosis of a solid tumor, OR advanced or metastatic disease that is refractory to conventional treatment or for which no standard therapy exists.
- Age > 18 years old.
- A performance status of ≥ 60 on the Karnofsky scale
- Life expectancy of at least 12 weeks.
- Patients must give written informed consent as per institutional and federal regulatory requirements.
- No chemotherapy, immunotherapy or radiotherapy for at least four weeks prior to entry in the study (six weeks for nitrosureas or mitomycin C). Patients may not receive concurrent chemotherapy, immunotherapy or radiotherapy while participating in this study. Patients may not receive concurrent treatment with any other investigational drug while on this protocol.
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- Patients must have measurable or evaluable disease by Response Evaluation Criteria in Solid Tumors (RECIST).
- Absolute granulocyte count of > 1,500/mm3 and a platelet count > 100,000/mm3.
- Patients must have adequate liver and renal function defined by a bilirubin of ≤ 2.0 mg/dl, and a creatinine of ≤ 1.5 mg/dl respectively.
- Patients must be able to stay in the general area for the duration of their treatment on this clinical research study.
- Men and women who are fertile must use adequate contraception. Premenopausal women must have a negative pregnancy test documented prior to study entry.
- Patients must be disease-free of prior invasive malignancies for >= 5 years with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
Who cannot join
- Individuals excluded from participating in this study are described below.
- Women who are pregnant or breast-feeding
- Patients with clinical signs of brain involvement or leptomeningeal disease.
- Patients with progressive sensory neuropathy or progressive hearing loss or tinnitus.
- Patients with other serious illness or medical conditions, including but not limited to the following:
- congestive heart failure or angina pectoris
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- previous history of myocardial infarction within 1 year from study entry
- uncontrolled hypertension or arrhythmias
- active infections
- unstable diabetes mellitus
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Luke's-Roosevelt Hospital Center
New York, New York, 10019
About this study
Official title: Phase I Study to Determine the Safety, Maximum Tolerated Dose, and Efficacy of Biweekly Oxaliplatin (Eloxatin) in Combination With Gemcitabine, Irinotecan, and 5-FU/Leucovorin (G-Flie) in Patients With Metastatic Solid Tumors or Adenocarcinoma of the Exocrine Pancreas
The purpose of this trial is to determine the maximum tolerated dose and the dose-limiting toxicity of biweekly oxaliplatin in combination with fixed doses of irinotecan, 5-fluorouracil/leucovorin and gemcitabine in patients with metastatic solid tumors or adenocarcinoma of the pancreas.
Read the detailed description
Pancreatic cancer is a major health problem in the United States and other developed nations. Approximately thirty thousand cases of adenocarcinoma of the exocrine pancreas are diagnosed in the United States each year. The majority of these tumors are unresectable at the time of diagnosis. Unresectable and metastatic pancreatic cancer is often resistant to treatment with response rates of less than 10% and median survival times of less than six months associated with single agent chemotherapy. As of July 2003, gemcitabine remains the standard of care palliative chemotherapy for patients with locally advanced or metastatic pancreatic cancer. This drug has modest clinical activity. In a phase III randomized controlled trial, 126 patients with advanced symptomatic pancreatic cancer were randomized to receive either gemcitabine 1000 mg/m2 weekly x 7 followed by a week of rest and then weekly x 3 every 4 weeks thereafter or fluorouracil 600 mg/m2 once weekly. The primary endpoint was a score of clinical benefit response (CBR) derived from a composite of pain, performance status, and weight. CBR was experienced by 24% of the gemcitabine treated patients compared with 5% of 5-FU treated patients. The median survival durations were 5.65 and 4.41 months for gemcitabine-treated and 5-FU-treated patients, respectively. The one year survival was 18% for patients treated with gemcitabine compared to 2% for patients treated with 5-FU. The effectiveness of gemcitabine may be improved by altering the standard infusion schedule to a fixed dose rate. Gemcitabine requires intracellular phosphorylation to form active di- and triphosphates, which is dose rate dependent. A phase II trial randomized patients to either receive gemcitabine 2200 mg/m2 over a standard 30 minute infusion or gemcitabine 1500 mg/m2 at a fixed rate of 10 mg/m2/min weekly x 3 every 4 weeks. The fixed rate infusion of 10 mg/m2/min was associated with a higher response rate of 16.6% v 2.7%, longer median survival 6.1 v 4.7 months, and a higher percentage of patients surviving one year or more, 23% v 0%. The fixed rate infusion schedule was also associated with significantly higher median gemcitabine triphosphate levels in peripheral circulating mononuclear cells after each infusion.
- Conditions
- Pancreatic Neoplasms
- Being tested
- gemcitabine; irinotecan; leucovorin; 5-fluorouracil; oxaliplatin
- Keywords
- solid tumors or adenocarcinoma of the exocrine pancreas
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gemcitabine; irinotecan; leucovorin; 5-fluorouracil; oxaliplatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the maximum tolerated dose (MTD) and the dose-limiting toxicity (DLT) of biweekly oxaliplatin in combination with fixed doses of irinotecan, 5-fluorouracil/leucovorin and gemcitabine
Secondary outcomes (1)
To document any antitumor activity with biweekly oxaliplatin in combination with fixed doses of irinotecan, 5-fluorouracil/leucovorin and gemcitabine administered on this schedule
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic NeoplasmsStudies 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Luke's-Roosevelt Hospital Center
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Investigators
- Peter Kozuch, Principal investigator, Continuum Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00220649
- Sponsor's protocol ID
- 175-03
- Other IDs
- OX-03-049
- Status last verified
- Aug 2009
- First submitted
- 16 Sep 2005
- Last updated
- 17 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study to Determine the Safety, Maximum Tolerated Dose, and Efficacy of Biweekly Oxaliplatin (Eloxatin) in Combination With Gemcitabine, Irinotecan, and 5-FU/Leucovorin (G-Flie) in Patients With Metastatic Solid Tumors or Adenocarcinoma of the Exocrine Pancreas
- ClinicalTrials.gov ID
- NCT00220649
- Acronym / sponsor ID
- 175-03
- Conditions
- Pancreatic Neoplasms
- Keywords
- solid tumors or adenocarcinoma of the exocrine pancreas
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- St. Luke's-Roosevelt Hospital CenterUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Mar 2004
- First posted
- 22 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.
The purpose of this trial is to determine the maximum tolerated dose and the dose-limiting toxicity of biweekly oxaliplatin in combination with fixed doses of irinotecan, 5-fluorouracil/leucovorin and gemcitabine in patients with metastatic solid tumors or adenocarcinoma of the pancreas.
Detailed description
Pancreatic cancer is a major health problem in the United States and other developed nations. Approximately thirty thousand cases of adenocarcinoma of the exocrine pancreas are diagnosed in the United States each year. The majority of these tumors are unresectable at the time of diagnosis. Unresectable and metastatic pancreatic cancer is often resistant to treatment with response rates of less than 10% and median survival times of less than six months associated with single agent chemotherapy. As of July 2003, gemcitabine remains the standard of care palliative chemotherapy for patients with locally advanced or metastatic pancreatic cancer. This drug has modest clinical activity. In a phase III randomized controlled trial, 126 patients with advanced symptomatic pancreatic cancer were randomized to receive either gemcitabine 1000 mg/m2 weekly x 7 followed by a week of rest and then weekly x 3 every 4 weeks thereafter or fluorouracil 600 mg/m2 once weekly. The primary endpoint was a score of clinical benefit response (CBR) derived from a composite of pain, performance status, and weight. CBR was experienced by 24% of the gemcitabine treated patients compared with 5% of 5-FU treated patients. The median survival durations were 5.65 and 4.41 months for gemcitabine-treated and 5-FU-treated patients, respectively. The one year survival was 18% for patients treated with gemcitabine compared to 2% for patients treated with 5-FU. The effectiveness of gemcitabine may be improved by altering the standard infusion schedule to a fixed dose rate. Gemcitabine requires intracellular phosphorylation to form active di- and triphosphates, which is dose rate dependent. A phase II trial randomized patients to either receive gemcitabine 2200 mg/m2 over a standard 30 minute infusion or gemcitabine 1500 mg/m2 at a fixed rate of 10 mg/m2/min weekly x 3 every 4 weeks. The fixed rate infusion of 10 mg/m2/min was associated with a higher response rate of 16.6% v 2.7%, longer median survival 6.1 v 4.7 months, and a higher percentage of patients surviving one year or more, 23% v 0%. The fixed rate infusion schedule was also associated with significantly higher median gemcitabine triphosphate levels in peripheral circulating mononuclear cells after each infusion.
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 (12 listed)
- Histologically or cytologically confirmed diagnosis of a solid tumor, OR advanced or metastatic disease that is refractory to conventional treatment or for which no standard therapy exists.
- Age > 18 years old.
- A performance status of ≥ 60 on the Karnofsky scale
- Life expectancy of at least 12 weeks.
- Patients must give written informed consent as per institutional and federal regulatory requirements.
Key exclusion criteria (10 listed)
- Individuals excluded from participating in this study are described below.
- Women who are pregnant or breast-feeding
- Patients with clinical signs of brain involvement or leptomeningeal disease.
- Patients with progressive sensory neuropathy or progressive hearing loss or tinnitus.
- Patients with other serious illness or medical conditions, including but not limited to the following:
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 |
|---|---|---|
| gemcitabine; irinotecan; leucovorin; 5-fluorouracil; oxaliplatin | Drug | – |
Primary outcome
To determine the maximum tolerated dose (MTD) and the dose-limiting toxicity (DLT) of biweekly oxaliplatin in combination with fixed doses of irinotecan, 5-fluorouracil/leucovorin and gemcitabine
1 secondary outcome
To document any antitumor activity with biweekly oxaliplatin in combination with fixed doses of irinotecan, 5-fluorouracil/leucovorin and gemcitabine administered on this schedule
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 17 Aug 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.
Peter Kozuch principal investigator
Continuum Cancer Center
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 gemcitabine; irinotecan; leucovorin; 5-fluorouracil; oxaliplatin in people with Pancreatic Neoplasms, run by St. Luke's-Roosevelt Hospital 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 12 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: finished, as of the sponsor's last update on 17 Aug 2009. 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 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?
To determine the maximum tolerated dose (MTD) and the dose-limiting toxicity (DLT) of biweekly oxaliplatin in combination with fixed doses of irinotecan, 5-fluorouracil/leucovorin and gemcitabine. 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 17 Aug 2009.