GTX Regimen for Biliary Cancers

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Brief Title

GTX Regimen for Biliary Cancers

Official Title

Phase II Study of the Gemzar, Taxotere and Xeloda Regimen (GTX) for Inoperable or Metastatic Adenocarcinoma of the Biliary System

Brief Summary

      This is a study for patients with advanced cancer of the biliary tree, such as
      cholangiocarcinoma. They will be treated with a chemotherapy regimen consisting of
      Gemcitabine, Taxotere, and Xeloda every 21 days for at least 9 weeks. Treatment will continue
      until their cancer progresses. This chemotherapy regimen has been used in pancreatic cancer
      and there is reason to believe that it will be effective for cancers of the biliary tree as
      well.
    

Detailed Description

      After initial presentation of our data concerning this regimen (in pancreatic cancer) at the
      2003 and 2004 ASCO meetings, a number of practitioners began using the regimen for pancreatic
      cancer patients. More importantly, several of these investigators began using the same
      regimen for patients with unresectable and metastatic biliary tree cancers, such as
      cholangiocarcinoma. In personal communications with us, they have cited the absence of
      reasonable alternatives as the primary reason to experiment with novel regimens. They have
      described to us case reports, whereby patients with cholangiocarcinoma had objective
      responses to this regimen. Personally, our group, in a pilot study, has treated 5 patients
      with the GTX regimen, and has documented 3 partial responses and 1 stable disease in 3
      patients afflicted with cholangiocarcinoma and 2 with gall bladder cancer. In this
      prospective study (to date 08/09), three patients have been enrolled and two of them achieved
      a partial response, by RECIST parameters, of >30% reduction in tumor size by cycle 3 (the
      first evaluation point). Therefore, we believe that GTX will show efficacy in treating this
      disease.

      Indeed, there is clinical evidence of efficacy of these drugs in cholangiocarcinomas. In a
      phase II trial, single agent gemcitabine produced a 30% partial response rate and a 30%
      stable disease rate in chemotherapy-naïve, cholangiocarcinoma patients.(8) A retrospective
      review of patients treated with combination fluorouracil (continuous infusion) and
      gemcitabine (30 minute infusion) demonstrated a 33% response rate and a 30% stable disease
      rate, with a median survival of 5.3 months. The low, observed rate of grade 3-4
      myelosuppression (11%) suggests this is a well tolerated regimen.(9) Likewise, gemcitabine
      and docetaxel have been combined in the treatment of these cancers, resulting in a 33%
      response rate and a 36% stable disease rate (3). We hope to improve upon these studies by
      substituting a sixty minute infusion rate for gemcitabine instead of the traditional thirty
      minute infusion, and by substituting capecitabine for infused fluorouracil. In addition, we
      have tested the GTX regimen in 2 cell lines in our lab: one cholangiocarcinoma and one gall
      bladder human line. We found that when GTX is given all at once to the cells, there is no
      increased cytotoxicity, but when given in the amount and dosing sequence that mimics the GTX
      regimen of this protocol, there is significant synergistic cytotoxicity. This synergism
      produces approximately a 3-fold increase in cell kill as compared with any other combination
      of the drugs or from any single drug in the GTX regimen. Given our laboratory data in
      cholangiocarcinoma cell lines that demonstrates synergy between these drugs, we are
      optimistic that we can produce superior results with less toxicities.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Response Rate

Secondary Outcome

 Toxicity

Condition

Biliary Cancer

Intervention

Gemcitabine, docetaxel, and capecitabine

Study Arms / Comparison Groups

 Treatment
Description:  Gemcitabine, docetaxel, and capecitabine

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

4

Start Date

August 2005

Completion Date

October 2010

Primary Completion Date

September 2010

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically confirmed adenocarcinoma of the intrahepatic or extrahepatic biliary
             tract including cholangiocarcinoma, gallbladder cancer and ampullary cancer (ampula of
             vater).

          -  Prior therapy with gemcitabine, Xeloda or docetaxel is acceptable if he/she only
             received and failed one of the 3 drugs.

          -  Prior experimental drug therapies such as Phase I agents are acceptable.

          -  Measurable disease: Any mass measurable by RECIST 1.1 parameters by CT or MRI scans of
             metastatic and primary tumor sites

          -  Ineligible for other high priority national or institutional studies

          -  Prior radiation and surgery allowed:

               -  3 weeks since surgery or last chemotherapy

               -  4 weeks since RT

          -  Non pregnant females with a negative serum β-HCG test within 1 week of starting the
             study, who are not breast feeding. Men and women of childbearing potential must be
             willing to consent to using effective contraception while on treatment and for a
             reasonable period thereafter.

          -  Clinical Parameters Life expectancy > 3 months Age ≥ 18 y.o Performance status 0-2
             (ECOG) (See Appendix IV) Peripheral Neuropathy must be ≤ grade 1 Able to tolerate oral
             chemotherapeutic medications

          -  Required initial laboratory data

        CBC with Differential Basic Metabolic Panel (BMP) Liver Function Tests (LFTs) Serum β-HCG
        (non-menopausal females) Tumor Specific Tests Hepatitis B and C Tests Pulse Oximetry on
        Room Air >90%

          -  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.

        Exclusion Criteria:

          -  Hypersensitivity: Patients with a history of severe hypersensitivity reaction to
             docetaxel or other drugs formulated with polysorbate 80 must be excluded.

          -  Prior malignancy in last 5 years other than: curatively treated carcinoma in-situ of
             the cervix, non-melanoma skin cancer, DCIS (ductal carcinoma in situ) or early stage
             (I or II) prostate cancer previously treated with curative intent by radiation and/or
             surgery and is now cancer free.

          -  Known serious medical or psychiatric illness preventing informed consent or intensive
             treatment (e.g., serious infection).

          -  Patients with CNS metastases shall be excluded.

          -  Patients with compromised immune systems are at increased risk of toxicity and lethal
             infections when treated with marrow-suppressive therapy. Therefore, HIV-positive
             patients are excluded from the study.

          -  Patients with currently active inflammatory bowel disease (ulcerative colitis,
             Crohn's) or sclerosing cholangitis will be excluded. A history of these IBD's or
             sclerosing cholangitis is acceptable if the disease is in remission or quiescent.

          -  Active infection with non-A hepatitis virus (Hepatitis B and C) will be excluded
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Robert L Fine, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00868998

Organization ID

AAAB3329


Responsible Party

Sponsor

Study Sponsor

Columbia University


Study Sponsor

Robert L Fine, MD, Principal Investigator, Columbia University


Verification Date

May 2016