Gemcitabine and Radiation Therapy in Treating Patients With Cancer of the Pancreas
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer |
Drug: gemcitabine hydrochloride Procedure: adjuvant therapy Radiation: radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase II Trial Of Adjuvant 2'2'-Difluoro-2'-Deoxycytidine (Gemcitabine) And External Beam Radiation For The Treatment Of Resectable Pancreatic Cancer |
| Study Start Date: | December 2000 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, North Carolina | |
| Comprehensive Cancer Center at Wake Forest University | |
| Winston-Salem, North Carolina, United States, 27157-1082 | |
| Study Chair: | Arthur William Blackstock, MD | Comprehensive Cancer Center of Wake Forest University |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00010166 History of Changes |
| Other Study ID Numbers: | CDR0000068452, CCCWFU-57198, NCI-104 |
| Study First Received: | February 2, 2001 |
| Last Updated: | August 20, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by Wake Forest University Baptist Medical Center:
|
stage I pancreatic cancer adenocarcinoma of the pancreas |
Additional relevant MeSH terms:
|
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Adjuvants, Immunologic Gemcitabine Immunologic Factors Physiological Effects of Drugs |
Pharmacologic Actions Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Radiation-Sensitizing Agents |
ClinicalTrials.gov processed this record on June 18, 2013