Prospective Phase I Study of GAX for Metastatic Pancreatic Cancer

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Brief Title

Prospective Phase I Study of GAX for Metastatic Pancreatic Cancer

Official Title

Prospective Phase I Study of Gax (Gemcitabine, ABRAXANE, and Xeloda) for Metastatic Pancreatic Cancer Protocol # TSH - APG - 2015-01

Brief 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.
    

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 Phase

Phase 1

Study Type

Interventional


Primary Outcome

Identification of Maximum Tolerated Dose and Dose Intensity in Patients with Pancreatic Cancer

Secondary Outcome

 Progression Free Survival

Condition

Pancreatic Cancer

Intervention

GAX - Gemcitabine, Abraxane and Xeloda

Study Arms / Comparison Groups

 Gemcitabine, ABRAXANE®, and Xeloda
Description:  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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

0

Start Date

February 2016

Completion Date

December 2016

Primary Completion Date

December 2016

Eligibility Criteria

        Inclusion Criteria:

          1. Histologically confirmed adenocarcinoma of pancreas metastatic to any distant site.
             (Stage IV).

          2. Must have a lesion reproducibly measurable by CT or MRI scans per Recist 1.1 criteria

          3. Prior radiation and surgery allowed (except Target lesions) but GAX treatment should
             be: >3 weeks since major surgery

               1. Bilirubin < 1.5 mg/dL

               2. 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.

               3. Patients must have adequate bone marrow function: Platelets >100,000, Hemoglobin
                  > 9.0g/dL and ANC > 1,500

               4. Patients must have adequate renal function: creatinine <1.5 mg/dL is recommended

          4. Women of childbearing potential and sexually active males must use an effective
             contraception method during treatment and for three months after completing treatment.

          5. Patients must have < Grade 2 pre-existing peripheral neuropathy (per CTCAE)

          6. 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

          7. 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.

          8. PT/PTT within normal or therapeutic limits as determined by the investigator. All
             subjects will be on Xeloda, use of warfarin is exclusionary.

        Exclusion Criteria:

          1. 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.

          2. 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® .

          3. 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.

          4. 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.

          5. 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.

          6. Patients with compromised immune systems who are at increased risk of toxicity and
             lethal infections when treated with marrow-suppressive therapy.

          7. 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).

          8. Serious non-healing wound, ulcer, or bone fracture.

          9. Evidence or history of bleeding diathesis.

         10. Major surgery, open biopsy or significant traumatic injury within 3 weeks of receiving
             first study drug.

         11. 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).

         12. 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.

             -
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Anthony Gulati, M.D, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02581501

Organization ID

StamfordH


Responsible Party

Sponsor

Study Sponsor

Stamford Hospital


Study Sponsor

Anthony Gulati, M.D, Principal Investigator, Stamford Hospital


Verification Date

April 2019