Pancreatic CancerPhase 1NCT02581501
Prospective Phase I Study of GAX for Metastatic Pancreatic Cancer
A Phase 1 study testing GAX - Gemcitabine, Abraxane and Xeloda in people with Pancreatic Cancer, run by Stamford Hospital at 1 site in United States.
Trial summary
GAX represents a novel approach to the development of cancer chemotherapy agents in pancreatic cancer and is based upon extensive laboratory investigations for the induction of apoptosis in pancreatic carcinoma cells. 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?
- GAX - Gemcitabine, Abraxane and Xeloda
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Dec 2016
- 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 confirmed adenocarcinoma of pancreas metastatic to any distant site. (Stage IV).
- Must have a lesion reproducibly measurable by CT or MRI scans per Recist 1.1 criteria
- Prior radiation and surgery allowed (except Target lesions) but GAX treatment should be: >3 weeks since major surgery
- Bilirubin < 1.5 mg/dL
- Patients must have adequate liver function: AST and ALT < 2.5 X upper limit of normal, alkaline phosphatase < 2.5 X upper limit of normal, unless bone metastasis is present (<5 X upper limit of normal) in the absence of liver metastasis.
- Patients must have adequate bone marrow function: Platelets >100,000, Hemoglobin > 9.0g/dL and ANC > 1,500
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- Patients must have adequate renal function: creatinine <1.5 mg/dL is recommended
- Women of childbearing potential and sexually active males must use an effective contraception method during treatment and for three months after completing treatment.
- Patients must have < Grade 2 pre-existing peripheral neuropathy (per CTCAE)
- Clinical Parameters Life expectancy > three months Age ≥ 18 years and ≤ 75 years Performance status 0-1 (ECOG) Pre-existing Peripheral Neuropathy (sensory) must be ˂ grade 2 Able to tolerate oral medications
- Informed Consent: Each patient must be completely aware of the nature of his/her disease process and must willingly give consent after being informed of the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts.
- PT/PTT within normal or therapeutic limits as determined by the investigator. All subjects will be on Xeloda, use of warfarin is exclusionary.
Who cannot join
- Neuroendocrine cancer should be ruled out by histology or immunohistochemical staining of the specimen. Mixed histology, pancreatic neuroendocrine and adenocarcinoma tumors, will also be excluded.
- Prior chemotherapy is allowed, as long as less than or equal to two of the components of GAX were used previously for their treatment: this includes gemcitabine, capecitabine, 5-FU, or ABRAXANE® .
- Hypersensitivity: Patients with a history of severe hypersensitivity reaction to taxanes or other drugs formulated with polysorbate 80, or any of the other drugs in the GAX regimen are excluded.
- Serious medical or psychiatric illness preventing informed consent or intensive treatment (e.g. serious infection) that would in the opinion of the investigator, increase the risk of serious neutropenic complications.
- Serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders, which could compromise the subject's safety or the study data integrity.
- Patients with compromised immune systems who are at increased risk of toxicity and lethal infections when treated with marrow-suppressive therapy.
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- Serious cardiovascular thromboembolic disease, including: congestive heart failure NYHA class III or greater; unstable angina or new onset angina (starting within three months of screening for this protocol), or myocardial infarction within the past 3 months (prior to screening); serious cardiac arrhythmias requiring therapy; cerebrovascular accident including transient ischemic attacks within the past 3 months (prior to screening).
- Serious non-healing wound, ulcer, or bone fracture.
- Evidence or history of bleeding diathesis.
- Major surgery, open biopsy or significant traumatic injury within 3 weeks of receiving first study drug.
- Use of cytochrome P450 enzyme inducing drugs such as: antiepileptic drugs (phenytoin, carbamazepine, or phenobarbital, but not Keppra), or St. John's Wort or rifampin (rifampicin).
- Prior malignancy in last 2 years other than curatively treated carcinoma in-situ of any site, non-melanoma skin cancer, or Stage I breast and/or bladder cancers (in situ), or early stage prostate cancer Stage I or II, curatively treated by surgery and/or radiation.
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Trial locations and contacts
1 site in 1 country.
United States1 site
Stamford Hospital Bennett Cancer Center
Stamford, Connecticut, 06904
About this study
Official title: Prospective Phase I Study of Gax (Gemcitabine, ABRAXANE, and Xeloda) for Metastatic Pancreatic Cancer Protocol # TSH - APG - 2015-01
GAX represents a novel approach to the development of cancer chemotherapy agents in pancreatic cancer and is based upon extensive laboratory investigations for the induction of apoptosis in pancreatic carcinoma cells.
Read the detailed description
It is the investigators expectation that this combination will induce apoptotic pathways downstream of biochemical mechanisms of resistance and synergistically induce pathways for apoptosis that are non-p53 dependent, which have not been previously explored in chemotherapy trials for this cancer. ABRAXANE® is novel in that it induces apoptosis to the same degree in mutant and wt p53 cancers. Mutant p53 tumors occur in 80-90% of PC and mutant p53 is thought of as one of the major mechanisms of drug resistance.
Furthermore, the investigators will be starting Xeloda and gemcitabine at slightly lower doses than the initial GTX studies. This is because the investigators have found that the efficacy is maintained at these slightly lower doses while side effects are minimized. The reason that GTX works at lower doses, as well as higher doses, is the synergy between drugs. Drug regimens that are synergistic can maintain their antitumor effect at doses lower than in non-synergistic regimens, but must maintain their dose intensity to achieve their anti-tumor effect. RECIST 1.1 criteria will be utilized for judging response, progression and stable disease. Overall assessment of the data will be by intention to treat analysis (ITT).
- Conditions
- Pancreatic Cancer
- Being tested
- GAX - Gemcitabine, Abraxane and Xeloda
- Keywords
- Xeloda, Gemcitabine, Abraxane, Pancreatic Cancer, Metastatic Cancer, Phase I, 5-FU, Capecitabine, Gemzar, NAB-Paclitaxel, Chemotherapy
- Medical subject headings
- Pancreatic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GAX - Gemcitabine, Abraxane and XelodaDrug
Also called Chemotherapy, Pancreatic Cancer
GAX represents a novel approach to the development of cancer chemotherapy agents in pancreatic cancer and is based upon extensive laboratory investigations for the induction of apoptosis in pancreatic carcinoma cells. It is our expectation that this combination will induce apoptotic pathways downstream of biochemical mechanisms of resistance and synergistically induce pathways for apoptosis that are non-p53 dependent, which have not been previously explored in chemotherapy trials for this cancer.
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine, ABRAXANE®, and Xeloda | Experimental | Level-1
ABRAXANE® 75 mg/m2 over 30 min Days 5 and 12
GEMCITABINE 600 mg/m2 over 60 min Days 5 and 12.
XELODA 500 mg/m2 BID D 1-14 capped at total dose of 2000 mg/day
Level 1
ABRAXANE® 100 mg/m2 over 30 min Days 5 and 12
GEMCITABINE 600 mg/m2 over 60 min Days 5 and 12
XELODA 500 mg/m2 BID D 1-14 capped at total dose of 2000 mg/day
Level 2
ABRAXANE® 125 mg/m2 over 30 min Days 5 and 12
GEMCITABINE 600 mg/m2 over 75 min Days 5 and 12
XELODA 500 mg/m2 BID D 1-14 capped at total dose of 2000 mg/day
Level 3
ABRAXANE® 125 mg/m2 over 30 min Days 5 and 12
GEMCITABINE 750 mg/m2 over 75 min Days 5 and 12
XELODA 500 mg/m2 BID D 1-14 capped at total dose of 2000 mg/day Receives: Drug: GAX - Gemcitabine, Abraxane and Xeloda |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of Maximum Tolerated Dose and Dose Intensity in Patients with Pancreatic Cancer
To determine the dose for Phase II study - identification of the maximum tolerated dose (MTD) and dose intensity in patients with advanced pancreatic cancer. As a Phase I study, primary objective is toxicity identification, not treatment efficacy.
Measured: 24 months
Secondary outcomes (1)
Progression Free Survival
To evaluate the response rate (using RECIST 1.1 criteria), the Progression free survival (PFS) and Overall Survival (OS) with treatment.
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study startFeb 2016
- Primary completionDec 2016
- Study completionDec 2016
Why it stopped: Due to no enrollment, Celgene (sponsor) withdrew funding
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stamford Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anthony Gulati, M.D, Principal investigator, Stamford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02581501
- Sponsor's protocol ID
- StamfordH
- Status last verified
- Apr 2019
- First submitted
- 19 Oct 2015
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Phase I Study of Gax (Gemcitabine, ABRAXANE, and Xeloda) for Metastatic Pancreatic Cancer Protocol # TSH - APG - 2015-01
- ClinicalTrials.gov ID
- NCT02581501
- Acronym / sponsor ID
- StamfordH
- Conditions
- Pancreatic Cancer
- Keywords
- Xeloda, Gemcitabine, Abraxane, Pancreatic Cancer, Metastatic Cancer, Phase I, 5-FU, Capecitabine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to no enrollment, Celgene (sponsor) withdrew funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stamford HospitalUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 21 Oct 2015 (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.
GAX represents a novel approach to the development of cancer chemotherapy agents in pancreatic cancer and is based upon extensive laboratory investigations for the induction of apoptosis in pancreatic carcinoma cells.
Detailed description
It is the investigators expectation that this combination will induce apoptotic pathways downstream of biochemical mechanisms of resistance and synergistically induce pathways for apoptosis that are non-p53 dependent, which have not been previously explored in chemotherapy trials for this cancer. ABRAXANE® is novel in that it induces apoptosis to the same degree in mutant and wt p53 cancers. Mutant p53 tumors occur in 80-90% of PC and mutant p53 is thought of as one of the major mechanisms of drug resistance.
Furthermore, the investigators will be starting Xeloda and gemcitabine at slightly lower doses than the initial GTX studies. This is because the investigators have found that the efficacy is maintained at these slightly lower doses while side effects are minimized. The reason that GTX works at lower doses, as well as higher doses, is the synergy between drugs. Drug regimens that are synergistic can maintain their antitumor effect at doses lower than in non-synergistic regimens, but must maintain their dose intensity to achieve their anti-tumor effect. RECIST 1.1 criteria will be utilized for judging response, progression and stable disease. Overall assessment of the data will be by intention to treat analysis (ITT).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine, ABRAXANE®, and Xeloda | Experimental | Drug: GAX - Gemcitabine, Abraxane and XelodaLevel-1 ABRAXANE® 75 mg/m2 over 30 min Days 5 and 12 GEMCITABINE 600 mg/m2 over 60 min Days 5 and 12. XELODA 500 mg/m2 BID D 1-14 capped at total dose of 2000 mg/day Level 1 ABRAXANE® 100 mg/m2 over 30 min Days 5 and 12 GEMCITABINE 600 mg/m2 over 60 min Days 5 and 12 XELODA 500 mg/m2 BID D 1-14 capped at total dose of 2000 mg/day Level 2 ABRAXANE® 125 mg/m2 over 30 min Days 5 and 12 GEMCITABINE 600 mg/m2 over 75 min Days 5 and 12 XELODA 500 mg/m2 BID D 1-14 capped at total dose of 2000 mg/day Level 3 ABRAXANE® 125 mg/m2 over 30 min Days 5 and 12 GEMCITABINE 750 mg/m2 over 75 min Days 5 and 12 XELODA 500 mg/m2 BID D 1-14 capped at total dose of 2000 mg/day |
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 confirmed adenocarcinoma of pancreas metastatic to any distant site. (Stage IV).
- Must have a lesion reproducibly measurable by CT or MRI scans per Recist 1.1 criteria
- Prior radiation and surgery allowed (except Target lesions) but GAX treatment should be: >3 weeks since major surgery
- Women of childbearing potential and sexually active males must use an effective contraception method during treatment and for three months after completing treatment.
- Patients must have < Grade 2 pre-existing peripheral neuropathy (per CTCAE)
Key exclusion criteria (13 listed)
- Neuroendocrine cancer should be ruled out by histology or immunohistochemical staining of the specimen. Mixed histology, pancreatic neuroendocrine and adenocarcinoma tumors, will also be excluded.
- Prior chemotherapy is allowed, as long as less than or equal to two of the components of GAX were used previously for their treatment: this includes gemcitabine, capecitabine, 5-FU, or ABRAXANE® .
- Hypersensitivity: Patients with a history of severe hypersensitivity reaction to taxanes or other drugs formulated with polysorbate 80, or any of the other drugs in the GAX regimen are excluded.
- Serious medical or psychiatric illness preventing informed consent or intensive treatment (e.g. serious infection) that would in the opinion of the investigator, increase the risk of serious neutropenic complications.
- Serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders, which could compromise the subject's safety or the study data integrity.
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 |
|---|---|---|
| GAX - Gemcitabine, Abraxane and XelodaAlso: Chemotherapy, Pancreatic CancerGAX represents a novel approach to the development of cancer chemotherapy agents in pancreatic cancer and is based upon extensive laboratory investigations for the induction of apoptosis in pancreatic carcinoma cells. It is our expectation that this combination will induce apoptotic pathways downstream of biochemical mechanisms of resistance and synergistically induce pathways for apoptosis that are non-p53 dependent, which have not been previously explored in chemotherapy trials for this cancer. | Drug | Gemcitabine, ABRAXANE®, and Xeloda |
Primary outcome
Identification of Maximum Tolerated Dose and Dose Intensity in Patients with Pancreatic Cancer
Time frame: 24 months
To determine the dose for Phase II study - identification of the maximum tolerated dose (MTD) and dose intensity in patients with advanced pancreatic cancer. As a Phase I study, primary objective is toxicity identification, not treatment efficacy.
1 secondary outcome
Progression Free Survival
Time frame: 6 years
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 Apr 2019.
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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.
Anthony Gulati, M.D principal investigator
Stamford Hospital
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 GAX - Gemcitabine, Abraxane and Xeloda in people with Pancreatic Cancer, run by Stamford 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 12 inclusion and 13 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 Apr 2019. 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 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?
Identification of Maximum Tolerated Dose and Dose Intensity in Patients with Pancreatic Cancer (time frame: 24 months). 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 18 Apr 2019.