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

• Sponsor: University of Maryland, Baltimore (Other)
• Overall Status: Completed
• CT.gov ID: NCT00390182
• Collaborator: Eli Lilly and Company (Industry)
• Enrollment: 38
• Locations: 2
• Arm: 1
• Duration (Months): 91
• Patients Per Site: 19
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Gastrointestinal Neoplasms; Ovarian Neoplasms	Drug: Gemcitabine	Phase 1/Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 38 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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)
• Study Start Date: Oct 1, 2003
• Actual Primary Completion Date: May 1, 2011
• Actual Study Completion Date: May 1, 2011

Arms and Interventions

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

1. Overall Response [3 weeks]

   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

1. Percentage of Participants With Distant Mestastases - Liver [Participants were followed for an average of 8 years]

   Patients with distant mestastases to the liver

2. Time of Advanced/Recurrent Disease Without Distant Metastases. [Participants were followed for an average of 8 years]

   Locally advanced/recurrent disease without distant metastases.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	University of Maryland & Baltimore VA medical centre	Baltimore	Maryland	United States	21201
2	Juravinski Cancer Centre	Hamilton	Ontario	Canada	L8V 5C2

Sponsors and Collaborators

• University of Maryland, Baltimore
• Eli Lilly and Company

Investigators

• Principal Investigator: William Regine, MD, Chair - University of Maryland

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Department of Radiation Oncology, Principal Investigator, University of Maryland, Baltimore
• ClinicalTrials.gov Identifier: NCT00390182
• Other Study ID Numbers: HP-00042314
• First Posted: Oct 19, 2006
• Last Update Posted: Mar 18, 2020
• Last Verified: Mar 1, 2020

• Keywords provided by Department of Radiation Oncology, Principal Investigator, University of Maryland, Baltimore: GI tumors; Locally Advanced; Metastatic; Hepatobiliary; Ovary
• Additional relevant MeSH terms: Neoplasms; Ovarian Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gemcitabine

Study Results

Participant Flow

Recruitment Details	All patients with cancer are seen by a multi-discipline clinic (medical, surgical, radiotherapy, etc). The PI or Co-PI identifies eligible candidates and initiates the discussion of research participation.

Arm/Group Title	Gem(1250mg/m2, d1, 8) +LDFRT (60cGy/fx BID, d1,2,8,9)
Arm/Group Description	4 cycles (1 cycle = 21 days): Gemcitabine 1250/m2 given IV Day 1 and Day 8; with concurrent Low Dose Fractionated Radiation Therapy (LDFRT). The total Radiation dose would be 19.2 Gy divided over 32 fractions. Treatment will be given in 2 fractions with a minimum 4 hr inter-fraction interval, not to exceed 6 hours. Radiotherapy given after the initiation of Gemcitabine Days 1,2,8, and 9.
Period Title: Overall Study
STARTED	38
COMPLETED	33
NOT COMPLETED	5

Baseline Characteristics

Arm/Group Title	Standard Chemotherapy, Gemcitabine With Concurrent Low Dose Ra
Arm/Group Description
Overall Participants	38
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	28 73.7%
>=65 years	10 26.3%
Sex: Female, Male (Count of Participants)
Female	17 44.7%
Male	21 55.3%
Region of Enrollment (participants) [Number]
United States	29 76.3%
Canada	9 23.7%

Outcome Measures

1. Primary Outcome

Title	Overall Response
Description	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.
Time Frame	3 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Low Dose Fractionated Radiation Therapy (LDFRT) + Gemcitabine
Arm/Group Description	Use of LDFRT with systemic gemcitabine is safe, tolerable, and potentially effective. In advanced pancreatic cancer, where response rates with single agent gemcitabine have been low, this chemopotentiation paradigm may improve survival among a poor prognostic patient cohort.
Measure Participants	25
Number [participants]	3 7.9%

2. Other Pre-specified Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Low Dose Fractionated Radiation Therapy (LDFRT) + Gemcitabine
Arm/Group Description	Use of LDFRT with systemic gemcitabine is safe, tolerable, and potentially effective. In advanced pancreatic cancer, where response rates with single agent gemcitabine have been low, this chemopotentiation paradigm may improve survival among a poor prognostic patient cohort.
Measure Participants	38
Number (95% Confidence Interval) [percentage of participants]	63 165.8%

3. Other Pre-specified Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Low Dose Fractionated Radiation Therapy (LDFRT) + Gemcitabine
Arm/Group Description	Use of LDFRT with systemic gemcitabine is safe, tolerable, and potentially effective. In advanced pancreatic cancer, where response rates with single agent gemcitabine have been low, this chemopotentiation paradigm may improve survival among a poor prognostic patient cohort.
Measure Participants	16
Median (95% Confidence Interval) [months]	7.5

Adverse Events

Arm/Group Title	Standard Chemotherapy, Gemcitabine With Concurrent Low Dose Ra
Arm/Group Description
All Cause Mortality
	Standard Chemotherapy, Gemcitabine With Concurrent Low Dose Ra
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Standard Chemotherapy, Gemcitabine With Concurrent Low Dose Ra
	Affected / at Risk (%)	# Events
Total	17/38 (44.7%)
Blood and lymphatic system disorders
Hematologic	17/38 (44.7%)	25
Other (Not Including Serious) Adverse Events
	Standard Chemotherapy, Gemcitabine With Concurrent Low Dose Ra
	Affected / at Risk (%)	# Events
Total	4/38 (10.5%)
Infections and infestations
Infection - non-neutropenic	4/38 (10.5%)	4

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.