Pemetrexed, Gemcitabine, and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT00310050|
Recruitment Status : Terminated (slow accrual)
First Posted : April 3, 2006
Results First Posted : November 30, 2018
Last Update Posted : November 30, 2018
RATIONALE: Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for their growth. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x-rays to kill tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of pemetrexed when given together with radiation therapy in treating patients with locally advanced pancreatic cancer.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: pemetrexed disodium Device: Radiotherapy||Phase 1|
- Determine the maximum tolerated dose of pemetrexed disodium when given in combination with upper abdominal radiotherapy after induction therapy comprising gemcitabine hydrochloride and pemetrexed disodium followed by consolidation therapy with gemcitabine hydrochloride in patients with locally advanced pancreatic cancer.
- Determine the quantitative toxicity of this regimen in these patients.
- Determine the quantitative and qualitative dose-limiting toxicities of pemetrexed disodium in combination with upper abdominal radiation therapy.
- Evaluate patterns of failure, response, and survival of these patients at 1 year
OUTLINE: This is an open-label, nonrandomized, dose-escalation study of pemetrexed disodium.
- Induction therapy: Patients receive pemetrexed disodium IV over 10 minutes and gemcitabine hydrochloride IV over 30 minutes on day 1. Treatment repeats every 14 days for 3 courses. Approximately 2 weeks later, patients without disease progression proceed to chemoradiotherapy.
- Chemoradiotherapy: Patients receive pemetrexed disodium IV over 10 minutes on days 1, 15, and 29 and undergo radiotherapy once daily 5 days a week for 5 ½ weeks. Approximately 2-3 weeks later, patients without disease progression proceed to consolidation therapy.
Cohorts of 3-9 patients receive escalating doses of pemetrexed disodium during chemoradiotherapy until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which ≤ 20% or ≤ 2 of 9 patients experience dose-limiting toxicity.
- Consolidation therapy: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Dose-Escalating Study of Induction Gemcitabine/Pemetrexed Followed by Pemetrexed and Concurrent Upper Abdominal Radiation Therapy in Patients With Locally Advanced Pancreatic Cancer|
|Study Start Date :||October 2005|
|Actual Primary Completion Date :||May 2008|
|Actual Study Completion Date :||May 2008|
Experimental: Pemetrexed in combination with concomitant radiotherapy
Patients will receive Pemetrexed plus Radiotherapy.
Drug: pemetrexed disodium
500 milligrams per meter squared day will be given during weeks 1, 3 and 5 of the radiation (3 total doses of Pemetrexed during the radiation therapy).
During the chemoradiation, the radiotherapy will be administered in 1.8 Gy/fractions after completion of the Pemetrexed infusion, and continue daily (Monday through Friday) for 5 1/2 weeks for a total delivered dose of 50.4 Gy (Total of 28 radiation treatments).
- Determine Maximum Tolerated Dose of Pemetrexed When Administered With Concomitant Radiation Therapy [ Time Frame: 42 days ]
- Quantitative Toxicity of Pemetrexed When Administered With Concomitant Radiation Therapy [ Time Frame: 42 days ]
- Qualitative Dose-limiting Toxicities of Pemetrexed in Combination With Radiation Therapy [ Time Frame: 42 days ]Toxicity will be determined using the revised NCI Common Toxicity Criteria (CTC) version 3.0 for Toxicity and Adverse Event Reporting. Number of events with grade 1-5 will be reported.
- Patterns of Failure [ Time Frame: 1 year ]
- Patterns of Response [ Time Frame: 1 year ]
- Number of Participants That Survived [ Time Frame: 1 year ]
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): NCT00310050
|United States, North Carolina|
|Wake Forest University Comprehensive Cancer Center|
|Winston-Salem, North Carolina, United States, 27157-1096|
|Study Chair:||Arthur William Blackstock, MD||Wake Forest University Health Sciences|