Genes as Predictors of Response to Gemcitabine, Docetaxel, and Capecitabine (GTX) in Metastatic or Unresectable Pancreatic Cancer.

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Brief Title

Genes as Predictors of Response to Gemcitabine, Docetaxel, and Capecitabine (GTX) in Metastatic or Unresectable Pancreatic Cancer.

Official Title

A Pilot Trial of Germline Polymorphisms as Predictors of Response to Gemcitabine, Docetaxel, and Capecitabine (GTX) in Metastatic or Unresectable Pancreatic Cancer.

Brief Summary

      This is a study for patients with advanced pancreatic cancer, using the drugs gemcitabine,
      docetaxel and capecitabine. Gemcitabine is a drug that has been approved by the FDA.
      Gemcitabine is been approved for treatment of cancer of the pancreas. It is also approved for
      treatment of lung cancer in combination with another drug called cisplatin. Docetaxel is a
      drug approved by the FDA. Docetaxel is approved for treatment of breast and lung cancer.
      Capecitabine is a drug approved by the FDA for treatment of cancer of the colon and rectum.
      This study will measure the levels of certain substances in participant's tumors. These
      substances (called genes, which are the cell's blueprint for these substances) affect how
      people's bodies react to the cancer drugs. Genes will also be measured in participant's
      blood. The purpose of this study is to see if these substances can predict survival and
      response in patients receiving the study drugs. In this study we wish to find out how long it
      takes for patients' cancers to worsen, and how long they survive after receiving the study
      drugs. The side effects of the combination of gemcitabine, docetaxel and capecitabine will
      also be evaluated.
    



Study Type

Interventional


Primary Outcome

To see if patients with advanced pancreatic cancer treated with gemcitabine, docetaxel and capecitabine who bear more favorable genotypes of genes involved in drug metabolisms are more likely to have response and survive longer than those that do not.

Secondary Outcome

 To assess time to progression, toxicity and to identify other molecular correlates of response, toxicity, and survival.

Condition

Pancreatic Cancer

Intervention

capecitabine, gemcitabine, docetaxel


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

1

Start Date

February 2005

Completion Date

July 2006

Primary Completion Date

June 2006

Eligibility Criteria

        Inclusion Criteria:

          -  Patients must have clinically documented unresectable or metastatic pancreatic cancer
             and histologic confirmation of the diagnosis with tumor.

          -  Tissue from tumor must be available. This may be paraffin embedded tissue from
             previous biopsy/resection or if it is not available, a repeat biopsy must be
             performed.

          -  Patients must agree to have a 20 cc blood sample drawn in addition to routine labs
             with each cycle of chemotherapy.

          -  Patients must have measurable disease by clinical exam or radiologic studies, that is
             at least one lesion measurable in at least one dimension, measuring 20mm. If prior
             radiation therapy was administered, measurable disease must be outside the radiation
             field.

          -  Patients may have received prior adjuvant chemotherapy and/or radiation therapy; this
             must have been completed at least 6 months prior to the initiation of therapy for
             metastatic disease.

          -  Patients must have a Zubrod performance status of 0-2.

          -  Peripheral Neuropathy must be less than grade 1

          -  Patients must have a predicted life expectancy of at least 12 weeks.

          -  Patients must have a pre-treatment granulocyte count (i.e., segmented neutrophils +
             bands) of greater than 1,500/mm3, a hemoglobin level of greater than or equal to 9.0
             gm/dl, and a platelet count of greater than 100,000/mm3.

          -  Patients must have adequate renal function as documented by a calculated creatinine
             clearance greater than 60.

          -  No major surgery within 1 month of starting study drug.

        Exclusion Criteria:

          -  Patients who have received prior adjuvant therapy with more than one of the following
             agents: gemcitabine, docetaxel or capecitabine

          -  Patients who have received prior treatment for metastatic or unresectable pancreatic
             cancer.

          -  Patients may not have a history of an allergy to gemcitabine, taxanes or
             fluoropyrimidines and polysorbate 80.

          -  Patients with any active or uncontrolled infection, including known HIV infection.

          -  Patients with psychiatric disorders that would interfere with consent or follow-up.

          -  Patients with a history of myocardial infarction within the previous six months or
             congestive heart failure requiring therapy.

          -  Pregnant or lactating women. Men and women of reproductive potential may not
             participate unless they have agreed to use an effective contraceptive method while on
             treatment and for at least 3 months thereafter.

          -  Presence of clinically apparent central nervous system metastases or carcinomatous
             meningitis

          -  Patients with a history of seizures are ineligible. Patients receiving phenytoin,
             phenobarbital, or other anti-epileptic prophylaxis are ineligible.

          -  Patients with any other severe concurrent disease, which in the judgment of the
             investigator would make the patient inappropriate for entry into this study.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Syma Iqbal, M.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00159471

Organization ID

3P-03-2


Responsible Party

Sponsor

Study Sponsor

University of Southern California

Collaborators

 Sanofi

Study Sponsor

Syma Iqbal, M.D., Principal Investigator, U.S.C. / Norris Comprehensive Cancer Center


Verification Date

May 2014