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Low Dose Radiation Therapy as Chemosensitizer in GI/ Ovarian Tumors (GCC0319)
This study is currently recruiting participants.
Study NCT00390182   Information provided by University of Maryland
First Received: October 17, 2006   Last Updated: June 29, 2009   History of Changes

October 17, 2006
June 29, 2009
October 2003
August 2009   (final data collection date for primary outcome measure)
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 ]
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.
Complete list of historical versions of study NCT00390182 on ClinicalTrials.gov Archive Site
 
 
 
Low Dose Radiation Therapy as Chemosensitizer in GI/ Ovarian Tumors
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

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).

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.

Phase I, Phase II
Interventional
Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
  • Gastrointestinal Neoplasms
  • Ovarian Neoplasms
Drug: Gemcitabine
Experimental:

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 The total dose would be 19.2 Gy divided over 32 fractions twice a day, on day 1 and day 8 after chemotherapy.

 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
65
August 2009
August 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: William Regine, MD 410-328-2326 wregine@umm.edu
Contact: Nancy L Kennedy, RN 410-328-2513 nkennedy@umm.edu
United States,   Canada
 
NCT00390182
Dr. William Regine, University of Maryland
H-22706
University of Maryland
Eli Lilly and Company
Principal Investigator: William Regine, MD Chair - University of Maryland
University of Maryland
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP