A Phase I Trial of Gemcitabine and Radiation in Locally Advanced Unresectable Cancer of the Pancreas
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| ClinicalTrials.gov Identifier: NCT00001431 |
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Recruitment Status :
Completed
First Posted : December 10, 2002
Last Update Posted : March 4, 2008
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Gastrointestinal Neoplasms Pancreatic Neoplasms | Drug: gemcitabine | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 20 participants |
| Primary Purpose: | Treatment |
| Official Title: | A Phase I Trial of Gemcitabine and Radiation in Locally Advanced Unresectable Cancer of the Pancreas |
| Study Start Date : | February 1995 |
| Study Completion Date : | November 2000 |
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically proven unresectable adenocarcinoma of the pancreas or ampulla of Vater. Surgical consult at NCI confirming unresectability fulfills requirement.
Unresectable disease defined as tumor with: Gross involvement of regional nodes or direct extension to any of the following sites: Duodenum, Spleen, Bile duct , Colon, Peripancreatic tissue, Adjacent large vessels, Stomach.
Metastatic disease requiring local radiotherapy allowed. No CNS metastasis.
No lymphomas or neuroendocrine tumors.
No peritoneal carcinomatosis.
PRIOR/CONCURRENT THERAPY:
Biologic Therapy: More than 4 weeks since immunotherapy.
Chemotherapy:
No prior chemotherapy for newly diagnosed disease.
More than 4 weeks since chemotherapy for recurrent disease (6 weeks since nitrosoureas, mitomycin, or suramin).
Endocrine Therapy: More than 4 weeks since hormonal therapy.
Radiotherapy:
No prior radiotherapy for newly diagnosed disease.
No prior abdominal or pelvic radiotherapy.
More than 4 weeks since radiotherapy for recurrent disease. No prior radiotherapy for locally advanced disease after resection allowed.
Surgery:
Prior resection allowed.
Biliary decompression or gastric bypass allowed.
PATIENT CHARACTERISTICS:
Age: 18 and over.
Performance status: ECOG 0-2.
Hematopoietic:
ANC greater than 2,000/mm(3).
Platelets greater than 100,000/mm(3).
Hepatic: AST/ALT no greater than 2.5 times normal.
Renal:
Creatinine less than 1.5 mg/dL.
Creatinine clearance at least 60 mL/min,
Cardiovascular:
No myocardial infarction within 6 months.
No unstable angina.
No congestive heart failure (NYHA class III/IV).
OTHER:
HIV seronegative.
No medical or psychiatric contraindication to protocol therapy.
No concurrent malignancy other than: Skin cancer, Cervical carcinoma in situ.
No pregnant or nursing women.
Adequate contraception required of fertile patients.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001431
| United States, Maryland | |
| National Cancer Institute (NCI) | |
| Bethesda, Maryland, United States, 20892 | |
| ClinicalTrials.gov Identifier: | NCT00001431 |
| Other Study ID Numbers: |
950075 95-C-0075 |
| First Posted: | December 10, 2002 Key Record Dates |
| Last Update Posted: | March 4, 2008 |
| Last Verified: | November 2000 |
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Combined Modality GI Cancer Pancreatic Cancer Radiotherapy |
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Neoplasms Pancreatic Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Gastrointestinal Diseases Gemcitabine |
Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |