Low Dose Upper Abdominal Radiation Therapy (LD-UART) + Gemcitabine in Patients With Advanced, Unresectable Pancreatic Cancer (PC) (GCC0319)

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Department of Radiation Oncology, University of Maryland
ClinicalTrials.gov Identifier:
NCT00390182
First received: October 17, 2006
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

The purposes of this study are:

  1. To assess the maximum tolerated dose of low-dose UART(Upper Abdominal Radiation Therapy ) or WART(Whole Abdominal Radiation Therapy) 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
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: GCC 0319: Low Dose Upper Abdominal Radiation Therapy (LD-UART) + Gemcitabine in Patients With Advanced, Unresectable Pancreatic Cancer (PC)

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • Overall Response [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.


Other Outcome Measures:
  • Percentage of Participants With Distant Mestastases - Liver [ Time Frame: Participants were followed for an average of 8 years ] [ Designated as safety issue: Yes ]
    Patients with distant mestastases to the liver

  • Time of Advanced/Recurrent Disease Without Distant Metastases. [ Time Frame: Participants were followed for an average of 8 years ] [ Designated as safety issue: Yes ]
    Locally advanced/recurrent disease without distant metastases.


Enrollment: 38
Study Start Date: October 2003
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm

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.

Other Names:
  • Gemzar
  • Gemcitabine
  • Radiation:External Radiation Therapy
  • **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:

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Maryland
University of Maryland & Baltimore VA medical centre
Baltimore, Maryland, United States, 21201
Canada, Ontario
Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Sponsors and Collaborators
Department of Radiation Oncology
Eli Lilly and Company
Investigators
Principal Investigator: William Regine, MD Chair - University of Maryland
  More Information

Additional Information:
No publications provided

Responsible Party: Department of Radiation Oncology, Principal Investigator, University of Maryland
ClinicalTrials.gov Identifier: NCT00390182     History of Changes
Other Study ID Numbers: HP-00042314
Study First Received: October 17, 2006
Results First Received: January 16, 2013
Last Updated: April 7, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Ovarian Neoplasms
Pancreatic Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Pancreatic Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 20, 2014