- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00864513
Study of Pemetrexed for Second-Line Pancreas Cancer
A Phase II Study of Pemetrexed as Second-Line Treatment in Patients With Pancreatic Cancer Progressing Despite Therapy With Gemcitabine
This study is for patients with pancreatic cancer that has grown and/or spread after having previously received the standard chemotherapy drug called gemcitabine.
In this study a drug called pemetrexed is being tested. This drug is approved by the FDA for use in lung cancer and mesothelioma. The purpose of this study is to see if pemetrexed keeps pancreas cancer that has grown and/or spread after gemcitabine from growing. Subjects will receive pemetrexed IV once every 21 days until disease progression or unacceptable side effects occur.
Studieöversikt
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
-
-
District of Columbia
-
Washington, District of Columbia, Förenta staterna, 20007
- Georgetown University Hospital/Lombardi Cancer Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Histologically confirmed adenocarcinoma of the pancreas
- Prior treatment for distant or locally advanced disease with gemcitabine-based therapy
- Measurable or evaluable disease
- ECOG performance status 0-2
- Adequate hematological parameters
- Adequate baseline liver function
- At least 28 days from any major surgery
- At least 2 weeks from the last radiation treatment
- Must have recovered from reversible toxicities of prior chemotherapy
- Must be able to discontinue any nonsteroidal anti-inflammatory medications
- Must be willing to receive intramuscular vitamin B12 shots and take oral folate supplements
Exclusion Criteria:
- Any prior treatment with pemetrexed
- More than one prior chemotherapy regimen
- HIV positive on antiretroviral therapy
- Pregnant or lactating
- Prior organ allograft
- On concurrent antitumor therapy including radiation therapy or other chemotherapies
- Creatinine clearance 45 ml/min or less
- Absolute neutrophil count < 1500
- Platelets < 75,000
- Bilirubin > 1.5 times the upper limit of normal
- Transaminases > 3 times the upper limit of normal except in known liver metastasis wherein they may be </= 5 times upper limit of normal
- Clinically significant ascites or pleural effusion that cannot be drained
- Any medical or psychiatric condition that may interfere with the ability to comply with protocol treatment
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: chemotherapy
pemetrexed
|
pemetrexed 500 mg/m2 IV day 1 of each 21 day cycle until disease progression or unacceptable toxicity for a maximum of 8 cycles
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Progression-free Survival
Tidsram: 6 months after last patient enrolled
|
Number of days from first dose of study treatment until the date of progression, as measured by worsening disease (new site of disease, or increase in existing disease) or death.
|
6 months after last patient enrolled
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Objective Response
Tidsram: Within two months of the completion of the last dose of chemotherapy
|
Evaluation of tumor extent by CT scans, according to RECIST criteria (a 20% decrease in the sum of the longest unidimensional measurements of existing disease), version 1.0
|
Within two months of the completion of the last dose of chemotherapy
|
CA 19-9 Response
Tidsram: Within two months of the last dose of chemotherapy
|
CA 19-9 was evaluatd every three weeks, before the next study treatment.
Approximately 30% of patients are not expected to have detectable CA 19-9, based on Lews-Y antigen.
CA 19-9 response is defined as more than 50% decrease from baseline.
|
Within two months of the last dose of chemotherapy
|
Number of Participants With Adverse Events
Tidsram: 30 days after last dose of study drug
|
Toxicity by National Cancer Institute Common Toxicity Criteria Adverse Event Version 3.0
|
30 days after last dose of study drug
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Jimmy J Hwang, M.D., Georgetown University
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Matsmältningssystemets sjukdomar
- Neoplasmer
- Neoplasmer efter plats
- Sjukdomar i det endokrina systemet
- Neoplasmer i matsmältningssystemet
- Neoplasmer i endokrina körtel
- Bukspottkörtelsjukdomar
- Pankreatiska neoplasmer
- Molekylära mekanismer för farmakologisk verkan
- Nukleinsyrasynteshämmare
- Enzyminhibitorer
- Antineoplastiska medel
- Folsyraantagonister
- Pemetrexed
Andra studie-ID-nummer
- IIT2007022
- 2007-022
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