Carcinoma, Pancreatic DuctalPhase 2NCT00226746
Efficacy Study of Gemcitabine, Paclitaxel, and Irradiation in the Treatment of Pancreatic Cancer
A Phase 2 study testing Paclitaxel and gemcitabine in people with Carcinoma, Pancreatic Ductal, run by New York Presbyterian Brooklyn Methodist Hospital at 1 site in United States.
Trial summary
The purpose of this study is to find out what effects, good and bad, the chemotherapy drugs gemcitabine (Gemzar) and paclitaxel (Taxol) have in combination with twice daily radiation treatment on locally advanced pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Pancreatic Ductal
- What is being tested?
- Paclitaxel and gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2003to Jun 2012
- 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
- Pathologically confirmed adenocarcinoma of the pancreas.
- Patients must have locally advanced/unresectable disease based on institutional standardized criteria of unresectability.
- Patients with residual disease after resection (R-1 or -2, micro and macroscopic residual) are eligible.
- Patients with biliary or gastroduodenal obstruction must have drainage prior to starting chemoradiation.
- All malignant disease must be encompassed within a single irradiation field (12 x 12 cm maximum).
- All patients must have radiographically assessable disease.
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- Electrocardiogram (EKG), chest x-ray, abdominal computed tomography (CT)/magnetic resonance imaging (MRI) scan must be obtained within four weeks of study entry.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Required entry laboratory parameters: granulocytes >/= 1,800/µl, platelet count >/= 100,000/µl, bilirubin < 2.0 mg/dL, alanine aminotransferase (ALT) < 3 x upper limit of normal, and creatinine < 3.0 mg/dL.
- Signed study-specific consent form prior to study entry.
Who cannot join
- Patients who have evidence of metastatic disease in the major viscera and/or peritoneal seeding or ascites.
- Previous irradiation to the planned field; or previous chemotherapy for pancreatic cancer (Gemzar® or Taxol®).
- Malignancy (within the past two years) except for non-melanomatous skin cancer or carcinoma in situ of the cervix, uterus, or bladder.
- Patients who have significant infection or other coexistent medical condition that would preclude protocol therapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Methodist Hospital
Brooklyn, New York, 11215
About this study
Official title: A Multicenter Phase II Trial of Weekly Gemcitabine, Paclitaxel, and Hyperfractionated External Irradiation (63.80 GY) for Locally Advanced Pancreatic Cancer
The purpose of this study is to find out what effects, good and bad, the chemotherapy drugs gemcitabine (Gemzar) and paclitaxel (Taxol) have in combination with twice daily radiation treatment on locally advanced pancreatic cancer.
Read the detailed description
Based on our previous experience with the use of a weekly paclitaxel dose of 60 mg/m2 and hyperfractionated radiation therapy 63.8 Gy, we are conducting this study incorporating the use of Gemcitabine at a dose level of 75 mg/m2/week in addition to our prior protocol.
- Conditions
- Carcinoma, Pancreatic Ductal
- Being tested
- Paclitaxel and gemcitabine
- Keywords
- Pancreatic Cancer, Hyperfractionated Radiation Therapy, Gemcitabine, Paclitaxel, Carcinoma, Pancreatic Ductal
- Medical subject headings
- Carcinoma, Pancreatic Ductal, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel and gemcitabineDrug
Radiation Therapy: 63.80 Gy (1.1 Gy twice a day X 58 fractions) Paclitaxel: 60 mg/m2 / week by 1- hour IV infusion on days 1, 8, 15, 22, 29, and 36.
Gemcitabine: 75 mg/m2 / week on days 1, 8, 15, 22, 29, and 36.
| Study group | Role | What they receive |
|---|---|---|
| Paclitaxel and Gemcitabine | Experimental | Radiation Therapy: 63.80 Gy (1.1 Gy twice a day X 58 fractions), Paclitaxel: 60 mg/m2 / week by 1- hour IV infusion on days 1, 8, 15, 22, 29, and 36.
Gemcitabine: 75 mg/m2 / week on days 1, 8, 15, 22, 29, and 36. Receives: Drug: Paclitaxel and gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
One-year overall survival rate
Follow up for survival will be done to know this outcome
Measured: Up to June 2010
Secondary outcomes (2)
Occurrence of grade 3 or higher toxicity in the gastrointestinal or pulmonary
Follow up for occurrence of adverse events will be done to know this outcome
Measured: year 2010
Occurrence of pathological response or shrinkage of the tumor (becomes resectable)
Follow up for tumor response will be done to know this outcome
Measured: year 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2005 (estimated)
- Study startMar 2003
- Primary completionJun 2010
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Pancreatic DuctalStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Radiation Therapy: 63.80 Gy (1.1 Gy BID X 58 fractions), Paclitaxel: 60 mg/m2 / week by 1- hour IV infusion on days 1, 8, 15, 22, 29, and 36. Gemcitabine: 75 mg/m2 / week on days 1, 8, 15, 22, 29, and 36.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York Presbyterian Brooklyn Methodist Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hani Ashamalla, MD, New York Presbyterian Brooklyn Methodist Hospital
- Investigators
- Hani Ashamalla, MD, FCCP, Principal investigator, New York Presbyterian Brooklyn Methodist Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00226746
- Sponsor's protocol ID
- NYM # 179; AM-05
- Status last verified
- Sep 2020
- First submitted
- 23 Sep 2005
- Last updated
- 18 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ashamalla H, Zaki B, Mokhtar B, Colella F, Selim H, Krishnamurthy M, Ross P. Hyperfractionated radiotherapy and paclitaxel for locally advanced/unresectable pancreatic cancer. Int J Radiat Oncol Biol Phys. 2003 Mar 1;55(3):679-87. doi: 10.1016/s0360-3016(02)03791-4.
PubMed 12573755
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase II Trial of Weekly Gemcitabine, Paclitaxel, and Hyperfractionated External Irradiation (63.80 GY) for Locally Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00226746
- Acronym / sponsor ID
- NYM # 179; AM-05
- Conditions
- Carcinoma, Pancreatic Ductal
- Keywords
- Pancreatic Cancer, Hyperfractionated Radiation Therapy, Gemcitabine, Paclitaxel, Carcinoma, Pancreatic Ductal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- New York Presbyterian Brooklyn Methodist HospitalUniversity, hospital or other
- Study start
- Mar 2003 (actual)
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 27 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 study is to find out what effects, good and bad, the chemotherapy drugs gemcitabine (Gemzar) and paclitaxel (Taxol) have in combination with twice daily radiation treatment on locally advanced pancreatic cancer.
Detailed description
Based on our previous experience with the use of a weekly paclitaxel dose of 60 mg/m2 and hyperfractionated radiation therapy 63.8 Gy, we are conducting this study incorporating the use of Gemcitabine at a dose level of 75 mg/m2/week in addition to our prior protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Radiation Therapy: 63.80 Gy (1.1 Gy BID X 58 fractions), Paclitaxel: 60 mg/m2 / week by 1- hour IV infusion on days 1, 8, 15, 22, 29, and 36. Gemcitabine: 75 mg/m2 / week on days 1, 8, 15, 22, 29, and 36.
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel and Gemcitabine | Experimental | Drug: Paclitaxel and gemcitabineRadiation Therapy: 63.80 Gy (1.1 Gy twice a day X 58 fractions), Paclitaxel: 60 mg/m2 / week by 1- hour IV infusion on days 1, 8, 15, 22, 29, and 36. Gemcitabine: 75 mg/m2 / week on days 1, 8, 15, 22, 29, and 36. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Pathologically confirmed adenocarcinoma of the pancreas.
- Patients must have locally advanced/unresectable disease based on institutional standardized criteria of unresectability.
- Patients with residual disease after resection (R-1 or -2, micro and macroscopic residual) are eligible.
- Patients with biliary or gastroduodenal obstruction must have drainage prior to starting chemoradiation.
- All malignant disease must be encompassed within a single irradiation field (12 x 12 cm maximum).
Key exclusion criteria (4 listed)
- Patients who have evidence of metastatic disease in the major viscera and/or peritoneal seeding or ascites.
- Previous irradiation to the planned field; or previous chemotherapy for pancreatic cancer (Gemzar® or Taxol®).
- Malignancy (within the past two years) except for non-melanomatous skin cancer or carcinoma in situ of the cervix, uterus, or bladder.
- Patients who have significant infection or other coexistent medical condition that would preclude protocol therapy.
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 and gemcitabineRadiation Therapy: 63.80 Gy (1.1 Gy twice a day X 58 fractions) Paclitaxel: 60 mg/m2 / week by 1- hour IV infusion on days 1, 8, 15, 22, 29, and 36. Gemcitabine: 75 mg/m2 / week on days 1, 8, 15, 22, 29, and 36. | Drug | Paclitaxel and Gemcitabine |
Primary outcome
One-year overall survival rate
Time frame: Up to June 2010
Follow up for survival will be done to know this outcome
2 secondary outcomes
Occurrence of grade 3 or higher toxicity in the gastrointestinal or pulmonary
Time frame: year 2010
Occurrence of pathological response or shrinkage of the tumor (becomes resectable)
Time frame: year 2010
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2020.
- Background: PubMed 12573755Ashamalla H, Zaki B, Mokhtar B, Colella F, Selim H, Krishnamurthy M, Ross P. Hyperfractionated radiotherapy and paclitaxel for locally advanced/unresectable pancreatic cancer. Int J Radiat Oncol Biol Phys. 2003 Mar 1;55(3):679-87. doi: 10.1016/s0360-3016(02)03791-4.
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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.
Hani Ashamalla, MD, FCCP principal investigator
New York Presbyterian Brooklyn Methodist Hospital
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 and gemcitabine in people with Carcinoma, Pancreatic Ductal, run by New York Presbyterian Brooklyn Methodist Hospital 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 10 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: withdrawn, as of the sponsor's last update on 18 Sep 2020. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
One-year overall survival rate (time frame: Up to June 2010). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00226746, which also lists 1 linked publication.
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 18 Sep 2020.