Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003157
Status:
COMPLETED
Last Update Posted:
2016-07-14
First Post:
1999-11-01
Brief Title:
Radiation Therapy and Chemotherapy in Treating Patients With Cancer of the Pancreas or Stomach
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Phase I Study of Gemcitabine Cisplatin and Radiation Therapy in Patients With Locally Advanced Pancreatic and Gastric Cancer
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage tumor cells Combining radiation therapy with chemotherapy may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of radiation therapy plus chemotherapy in treating patients who have cancer of the pancreas or stomach
PURPOSE Phase I trial to study the effectiveness of radiation therapy plus chemotherapy in treating patients who have cancer of the pancreas or stomach
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of gemcitabine and cisplatin that can be administered during a standard course of radiation therapy for patients with unresectable or locally recurrent pancreatic and gastric cancer II Describe the tolerance of gemcitabine cisplatin and radiation therapy in this patient population III Seek preliminary evidence of the therapeutic activity of this regimen in this patient population as measured by survival
OUTLINE This is a dose escalation study Patients undergo radiotherapy to the tumor and lymph nodes followed by a decrease in radiotherapy to the tumor alone Radiation therapy is administered for a total of 55 weeks Patients receive intravenous gemcitabine twice weekly on Tuesday and Friday over the first 3 weeks of radiotherapy Cisplatin is administered intravenously twice weekly following gemcitabine therapy Three patients are treated at each dose level Dose escalation does not occur until all patients at a given dose level have completed radiotherapy and returned for a 4 week follow up The dose limiting toxicity DLT is defined as the dose at which at least 2 of 6 patients experience unacceptable toxic effects The maximum tolerated dose is defined as the dose at which no more than 1 of 6 patients experiences DLT Patients exhibiting stable disease remain on therapy until disease progression or intolerable toxic effects Patients experiencing toxic effects and no disease progression are retreated at a lower dose Patients are followed every 3 months for the first 2 years then every 6 months for the next year
OUTLINE This is a dose escalation study Patients undergo radiotherapy to the tumor and lymph nodes followed by a decrease in radiotherapy to the tumor alone Radiation therapy is administered for a total of 55 weeks Patients receive intravenous gemcitabine twice weekly on Tuesday and Friday over the first 3 weeks of radiotherapy Cisplatin is administered intravenously twice weekly following gemcitabine therapy Three patients are treated at each dose level Dose escalation does not occur until all patients at a given dose level have completed radiotherapy and returned for a 4 week follow up The dose limiting toxicity DLT is defined as the dose at which at least 2 of 6 patients experience unacceptable toxic effects The maximum tolerated dose is defined as the dose at which no more than 1 of 6 patients experiences DLT Patients exhibiting stable disease remain on therapy until disease progression or intolerable toxic effects Patients experiencing toxic effects and no disease progression are retreated at a lower dose Patients are followed every 3 months for the first 2 years then every 6 months for the next year
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000065949 | REGISTRY | PDQ Physician Data Query | None |