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Low Dose Radiation Therapy as Chemosensitizer in GI/ Ovarian Tumors (GCC0319)

This study is currently recruiting participants.
Verified by University of Maryland, June 2008

Sponsors and Collaborators: University of Maryland
Eli Lilly and Company
Information provided by: University of Maryland
ClinicalTrials.gov Identifier: NCT00390182
  Purpose

The purposes of this study are:

  1. To assess the maximum tolerated dose of low-dose UART or WART given in combination with standard fixed dose-rate Gemcitabine in patients with advanced gastrointestinal (GI) or ovarian tumors (Phase I).
  2. To assess response rate and survival in advanced upper GI tumors following completion of therapy (Phase II).

Condition Intervention Phase
Gastrointestinal Neoplasms
Ovarian Neoplasms
Drug: Gemcitabine
Radiation: External Radiation Therapy
Phase I
Phase II

MedlinePlus related topics:   Cancer    Ovarian Cancer   

ChemIDplus related topics:   Gemcitabine hydrochloride    Gemcitabine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:   GCC 0319: A Phase I/II Study of Low-Dose Upper Abdominal Radiation Therapy (UART) or Whole (W) ART as Chemosensitizer in Patients With Locally Advanced or Metastatic Tumors of the Gastrointestinal Tract or Ovary

Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • The primary goal of the Phase I aspect of this study is to determine the maximally tolerated dose (MTD) schedule of low dose UART or WART with 4 cycles of fixed systemic doses of gemcitabine. [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:   65
Study Start Date:   October 2003
Estimated Study Completion Date:   August 2008
Estimated Primary Completion Date:   August 2008 (Final data collection date for primary outcome measure)

Intervention Details:
    Drug: Gemcitabine
    Gemcitabine will be given at 1250 mg per meter squared over 2 hours days 1 and 8 of a 21 day cycle for a total of 4 cycles.
    Radiation: External Radiation Therapy
    Patients will be treated with Low-dose upper-abdominal radiation therapy (UART). AP/PA kidney blocks will be used to keep maximum kidney dose to < 20 Gy. Radiation therapy will be given on the days of and the day after each administration of Gemcitabine. Treatment will be given in 2 fractions with a minimum 4 hr inter-fraction interval, not to exceed 6 hours. The total dose would be 19.2 Gy divided over 32 fractions. The first fraction of radiotherapy will be given after the initiation of Gemcitabine.
Detailed Description:

Before entering this study the doctor will examine the patient and order blood tests. These tests will use approximately 10 ml of blood. Blood work should be done within 3 weeks prior to treatment.. Women of child-bearing potential are required to have a pregnancy test done within 7 days prior to the start of treatment . A CT or a PET/CT scan of the chest, abdomen and pelvis will be done within 4 weeks prior to starting treatment . All subjects participating in this study will receive radiation therapy and chemotherapy. Patients will get 4 cycles of chemotherapy along with radiation. Each cycle of chemotherapy consists of gemcitabine given i.v. on day 1 and day 8 of treatment. XRT is given on days 1 and 2 and on days 8 and 9 twice a day. This works out to 8 treatments of XRT per course of chemo. Overall, a total of 32 treatments of radiation therapy will be given during the 4 sessions of chemotherapy. Blood work for CBC with differential and platelets will be done prior to each dose of chemotherapy.The investigational portion of this study is the radiation therapy given to the abdomen on the same day and the day after the patient receives chemotherapy. Three-Four weeks after treatment completion the patient will be evaluated again. The treating physician will examine the patient and order blood tests. These tests will use approximately 10 ml of blood. The physician will also order a repeat CT or PET/CT to compare the disease status after treatment. These tests are not experimental and are part of routine check-ups of patients with pancreatic cancer. Patients will be followed for survival. Protected health information will not be reviewed by someone other than the patient's provider to identify potential subjects.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  1. Patients are eligible if they have newly diagnosed histologically confirmed locally advanced or metastatic tumors of the pancreas. Patients must be felt to be unresectable by surgical criteria or felt to be medically inoperable. Patients may also be Stage IV with metastatic disease to the liver. Patients with bone and/or lung metastasis may be included at the investigators discretion.
  2. Patients must have measurable disease by CT scan.
  3. Patients must be able to give informed consent. Patients must be older than 18 years of age.
  4. Patients should have adequate bone marrow, renal, and hepatic function including: Bilirubin less than 1.25 x institutional normal LDH SGPT, SGOT, and alkaline phosphatase less than3 x institutional normal Serum creatinine less than or equal to 3 mg/dl. Absolute neutrophil count of greater than 1500 Hemoglobin greater than 9 gm per dl Platelet count greater than 100,000 WBC greater than 3000 cells per mcl
  5. Women of child-bearing potential must be agreeable to adequate contraception.(hormonal or barrier method of birth control) prior to study entry and for the duration of study participation.)
  6. Patients must have a Karnofsky performance status of greater than or equal 60 or Zubrod of less or equal to 2.
  7. Life expectancy of at least 3 months.
  8. May have had a second malignancy or multiple malignancies if adequately controlled by clinical means. patients with more than one type of cancer must be cleared by the principal investigator.
  9. Patients must be at least 1 week from any major operative procedure.

10 .Patients may have brain metastasis if these brain metastasis are well controlled by usual clinical criteria and if the life expectancy is at least 3 months. Any patient with brain metastasis must be cleared by the principal investigator.

Exclusion Criteria:

  1. Active infection requiring intravenous (IV) antibiotics at the time of entry.
  2. Cerebral metastasis which has not been adequately controlled.
  3. Significant malnutrition, cachexia, inundation or inability to give informed consent by clinical assessment.
  4. Concurrent chemotherapy not prescribed in this protocol.
  5. Any significant medical problems such as diabetes, cardiomyopathy or hypertension which is not reasonably controlled
  6. Prior radiation or chemotherapy
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00390182

Contacts
Contact: William Regine, MD     410-328-2326     wregine@umm.edu    
Contact: Nancy L Kennedy, RN     410-328-2513     nkennedy@umm.edu    

Locations
United States, Maryland
University of Maryland & Baltimore VA medical centre     Recruiting
      Baltimore, Maryland, United States, 21201
      Contact: William Regine, M.D.            
Canada, Ontario
Juravinski Cancer Centre     Recruiting
      Hamilton, Ontario, Canada, L8V 5C2
      Contact: Raimond Wong, MD     905-387-9495 ext 64704        

Sponsors and Collaborators
University of Maryland
Eli Lilly and Company

Investigators
Principal Investigator:     William Regine, MD     Chair - University of Maryland    
  More Information

Clinical Trial Details for Study "GCC 0319"  This link exits the ClinicalTrials.gov site
 

Responsible Party:   University of Maryland ( Dr. William Regine )
Study ID Numbers:   22706
First Received:   October 17, 2006
Last Updated:   June 5, 2008
ClinicalTrials.gov Identifier:   NCT00390182
Health Authority:   United States: Institutional Review Board

Keywords provided by University of Maryland:
GI tumors  
Locally Advanced  
Metastatic  
Hepatobiliary  
Ovary  

Study placed in the following topic categories:
Ovarian cancer
Ovarian Neoplasms
Digestive System Neoplasms
Gastrointestinal Diseases
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Genital Diseases, Female
Digestive System Diseases
Neoplasm Metastasis
Gastrointestinal Neoplasms
Endocrinopathy
Gemcitabine
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Adnexal Diseases
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 05, 2008




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