Gemcitabine and Radiation Therapy in Treating Patients With Cancer of the Pancreas

NCT ID: NCT00010166

Last Updated: 2021-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-12-01
• Study Completion Date: 2003-10-03

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Gemcitabine may make tumor cells more sensitive to radiation therapy. Combining chemotherapy with radiation therapy after surgery may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with radiation therapy in treating patients who have undergone surgery to remove cancer of the pancreas.

Detailed Description

OBJECTIVES:

• Determine the time to disease progression, local control, and survival of patients with previously resected pancreatic cancer treated with adjuvant gemcitabine and radiotherapy.

OUTLINE: This is a multicenter study.

Patients receive gemcitabine IV over 30-60 minutes on days 1, 4, 8, 11, 15, 18, 22, 25, 29, and 32 and undergo radiotherapy on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-38 in the absence of disease progression or unacceptable toxicity.

Beginning at least 4 weeks after chemoradiotherapy, patients without disease progression and with less than 10% weight loss during study receive additional gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for a total of 2 courses.

Patients are followed every 8 weeks for 6 months and then every 3 months for up to 2 years.

PROJECTED ACCRUAL: A total of 72 patients will be accrued for this study within 2.2 or 3.4 years.

Conditions

Pancreatic Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

gemcitabine hydrochloride

Intervention Type: DRUG

adjuvant therapy

Intervention Type: PROCEDURE

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed invasive adenocarcinoma of the pancreas

• Prior gross total resection via a pancreaticoduodenectomy (Whipple resection or total pancreatectomy) within the past 2 months
• No clinical evidence of gross residual disease at time of surgery

• No focally positive margins (tumor at the margin)
• No unresected nodal disease or metastatic disease to the liver, peritoneal surfaces, or elsewhere

PATIENT CHARACTERISTICS:

Age:

• Over 18

Performance status:

• ECOG 0-2

Life expectancy:

• More than 6 months

Hematopoietic:

• Granulocyte count greater than 1,500/mm3
• Hemoglobin greater than 10 g/dL
• Platelet count greater than 100,000/mm3

Hepatic:

• Bilirubin less than 2.0 mg/dL

Renal:

• Creatinine less than 2.0 mg/dL

Other:

• Able to maintain adequate oral nutrition
• Documented stable weight (no more than 5 lbs weight loss) for at least 2 weeks prior to study
• No other malignancy within the past 2 years except inactive nonmelanoma skin cancer or carcinoma in situ of the cervix or breast
• Non-metastatic prostate cancer allowed if more than 2 year survival likely
• No other serious medical or psychiatric illness that would preclude study or limit survival to less than 2 years
• Not pregnant
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No concurrent routine growth factors

Chemotherapy:

• No prior chemotherapy for pancreatic cancer

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior abdominal radiotherapy for pancreatic cancer

Surgery:

• See Disease Characteristics

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arthur William Blackstock, MD

Role: STUDY_CHAIR

Wake Forest University Health Sciences

Locations

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, United States

Countries

United States

References

Blackstock AW, Mornex F, Partensky C, Descos L, Case LD, Melin SA, Levine EA, Mishra G, Limentani SA, Kachnic LA, Tepper JE. Adjuvant gemcitabine and concurrent radiation for patients with resected pancreatic cancer: a phase II study. Br J Cancer. 2006 Aug 7;95(3):260-5. doi: 10.1038/sj.bjc.6603270. Epub 2006 Jul 25.

Reference Type: RESULT

PMID: 16868545 (View on PubMed)

Other Identifiers

CCCWFU-57198

Identifier Type: -

Identifier Source: secondary_id

NCI-104

Identifier Type: -

Identifier Source: secondary_id

REBACDR0000068452

Identifier Type: -

Identifier Source: org_study_id