Low Dose Radiation Therapy as Chemosensitizer in GI/ Ovarian Tumors - Full Text View

Sponsor:	University of Maryland
Collaborator:	Eli Lilly and Company
Information provided by:	University of Maryland
ClinicalTrials.gov Identifier:	NCT00390182

Purpose

The purposes of this study are:

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).
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	Phase I Phase II

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer Warts

Drug Information available for: Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

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 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Single Arm: 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.	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 The total dose would be 19.2 Gy divided over 32 fractions twice a day, on day 1 and day 8 after chemotherapy. **Radiation is the experimental part of the study.

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:

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.
Patients must have measurable disease by CT scan.
Patients must be able to give informed consent. Patients must be older than 18 years of age.
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
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.)
Patients must have a Karnofsky performance status of greater than or equal 60 or Zubrod of less or equal to 2.
Life expectancy of at least 3 months.
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.
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:

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

Additional Information:

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

No publications provided

Responsible Party:	University of Maryland ( Dr. William Regine )
Study ID Numbers:	H-22706
Study First Received:	October 17, 2006
Last Updated:	June 29, 2009
ClinicalTrials.gov Identifier:	NCT00390182 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Maryland:

GI tumors
Locally Advanced
Metastatic
Hepatobiliary
Ovary

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Gonadal Disorders
Antineoplastic Agents
Physiological Effects of Drugs
Urogenital Neoplasms
Ovarian Diseases
Genital Diseases, Female
Neoplasms by Site
Therapeutic Uses
Gemcitabine

Endocrine Gland Neoplasms
Ovarian Neoplasms
Digestive System Neoplasms
Genital Neoplasms, Female
Endocrine System Diseases
Enzyme Inhibitors
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Adnexal Diseases
Neoplasms
Digestive System Diseases
Radiation-Sensitizing Agents
Gastrointestinal Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009