Clinical trialPhase 1Terminated
Pemetrexed, Gemcitabine, and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer
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
- Outcome
- Stopped earlyslow accrual (Enrollment)
- Phase
- Phase 1
- Status
- Terminated
- Study type
- Interventional
- Start
- October 2005
- Expected end
- May 2008
- Enrollment
- 4 participants
- Sites
- 1
- Primary outcomes
- Determine Maximum Tolerated Dose of Pemetrexed When Administered With Concomitant Radiation Therapy; Quantitative Toxicity of Pemetrexed When Administered With Concomitant Radiation Therapy
- Sponsor
- Other
- Results posted
- 2018-11-30
- Last update
- 30 November 2018
These are registry fields. A trial card, with population, design, endpoints and result direction each tied to a quote, is not in the data yet.
Ask this document
Answers come only from this document’s own text, as highlighted quotes. If it doesn’t say, you are told so instead of given a guess.
Try
Source text
Brief summary public domain (ClinicalTrials.gov)
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.
Detailed description public domain (ClinicalTrials.gov)
OBJECTIVES: Primary * 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. Secondary * 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.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Determine Maximum Tolerated Dose of Pemetrexed When Administered With Concomitant Radiation Therapy [42 days].
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Quantitative Toxicity of Pemetrexed When Administered With Concomitant Radiation Therapy [42 days].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Qualitative Dose-limiting Toxicities of Pemetrexed in Combination With Radiation Therapy [42 days]. Number, events. Grade 1: Pemetrexed in Combination With Concomitant Radiotherapy (n=2): 22. Grade 2: Pemetrexed in Combination With Concomitant Radiotherapy (n=2): 7. Grade 3: Pemetrexed in Combination With Concomitant Radiotherapy (n=2): 3. Grade 4: Pemetrexed in Combination With Concomitant Radiotherapy (n=2): 0. Grade 5: Pemetrexed in Combination With Concomitant Radiotherapy (n=2): 0.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Patterns of Failure [1 year].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Patterns of Response [1 year]. Count Of Participants, Participants. Partial Response: Pemetrexed in Combination With Concomitant Radiotherapy (n=3): 1. Stable disease: Pemetrexed in Combination With Concomitant Radiotherapy (n=3): 2.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Number of Participants That Survived [1 year]. Count Of Participants, Participants. Pemetrexed in Combination With Concomitant Radiotherapy (n=3): 2.