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

Primary Purpose

Gastrointestinal Neoplasms, Ovarian Neoplasms

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

Gemcitabine

About this trial

This is an interventional treatment trial for Gastrointestinal Neoplasms focused on measuring GI tumors, Locally Advanced, Metastatic, Hepatobiliary, Ovary

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Maryland & Baltimore VA medical centre
Juravinski Cancer Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Arm

Arm Description

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.

Outcomes

Primary Outcome Measures

Overall Response

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00390182

First Posted

October 17, 2006

Last Updated

March 16, 2020

Sponsor

University of Maryland, Baltimore

Collaborators

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT00390182

Brief Title

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

Acronym

GCC0319

Official Title

GCC 0319: Low Dose Upper Abdominal Radiation Therapy (LD-UART) + Gemcitabine in Patients With Advanced, Unresectable Pancreatic Cancer (PC)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

October 2003 (undefined)

Primary Completion Date

May 2011 (Actual)

Study Completion Date

May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Maryland, Baltimore

Collaborators

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purposes of this study are: 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). To assess response rate and survival in advanced upper GI tumors following completion of therapy (Phase II).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastrointestinal Neoplasms, Ovarian Neoplasms

Keywords

GI tumors, Locally Advanced, Metastatic, Hepatobiliary, Ovary

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

38 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single Arm

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Other Intervention Name(s)

Gemzar, Radiation:External Radiation Therapy, **Radiation is the experimental part of the study.

Intervention Description

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.

Primary Outcome Measure Information:

Title

Overall Response

Description

Time Frame

3 weeks

Other Pre-specified Outcome Measures:

Title

Percentage of Participants With Distant Mestastases - Liver

Description

Patients with distant mestastases to the liver

Time Frame

Participants were followed for an average of 8 years

Title

Time of Advanced/Recurrent Disease Without Distant Metastases.

Description

Locally advanced/recurrent disease without distant metastases.

Time Frame

Participants were followed for an average of 8 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

William Regine, MD

Organizational Affiliation

Chair - University of Maryland

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Maryland & Baltimore VA medical centre

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201

Country

United States

Facility Name

Juravinski Cancer Centre

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8V 5C2

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

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

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