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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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Gastrointestinal Neoplasms, Ovarian Neoplasms

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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.

Outcome Time Frame:

3 weeks

Safety Issue:

Yes

Principal Investigator

William Regine, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chair - University of Maryland

Authority:

United States: Institutional Review Board

Study ID:

HP-00042314

NCT ID:

NCT00390182

Start Date:

October 2003

Completion Date:

May 2011

Related Keywords:

  • Gastrointestinal Neoplasms
  • Ovarian Neoplasms
  • GI tumors
  • Locally Advanced
  • Metastatic
  • Hepatobiliary
  • Ovary
  • Neoplasms
  • Gastrointestinal Neoplasms
  • Digestive System Neoplasms
  • Ovarian Neoplasms

Name

Location

University of Maryland & Baltimore VA medical centreBaltimore, Maryland  21201