Pemetrexed Disodium Plus Gemcitabine in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
5 december 2016 uppdaterad av: Alliance for Clinical Trials in Oncology
A Phase II Clinical Trial Evaluating Three Schedules Of ALIMTA Plus Gemcitabine As Frontline Chemotherapy For Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug and giving the drugs in different ways may kill more tumor cells.
PURPOSE: Randomized phase II trial to compare the effectiveness of three different regimens of pemetrexed disodium plus gemcitabine in treating patients who have locally advanced or metastatic non-small cell lung cancer.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
OBJECTIVES:
- Compare the tumor response rates in patients with locally advanced or metastatic non-small cell lung cancer treated with 3 different schedules of pemetrexed disodium and gemcitabine.
- Compare the duration of response, time to progressive disease, time to treatment failure, and survival time in patients treated with these regimens.
- Compare the quantitative and qualitative toxic effects of these regimens in these patients.
OUTLINE: This is a randomized, open-label study. Patients are stratified according to stage of disease (IIIB vs IV) and ECOG performance status (0 vs 1). Patients are randomized to one of three treatment arms.
- Arm I: Patients receive pemetrexed disodium IV over 10 minutes on day 1 followed by gemcitabine IV over 30 minutes on days 1 and 8.
- Arm II: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 followed by pemetrexed disodium IV over 10 minutes on day 1.
- Arm III: Patients receive gemcitabine IV over 30 minutes on day 1 and pemetrexed disodium IV over 10 minutes followed by gemcitabine IV over 30 minutes on day 8.
Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may receive up to 6 additional courses of therapy.
Patients are followed every 2 months for 1 year and then every 6 months for 4 years.
PROJECTED ACCRUAL: A total of 180 patients (60 per treatment arm) will be accrued for this study within 20 months.
Studietyp
Interventionell
Inskrivning (Faktisk)
157
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Arizona
-
Scottsdale, Arizona, Förenta staterna, 85259-5404
- CCOP - Scottsdale Oncology Program
-
-
Florida
-
Jacksonville, Florida, Förenta staterna, 32224
- Mayo Clinic
-
-
Illinois
-
Peoria, Illinois, Förenta staterna, 61602
- CCOP - Illinois Oncology Research Association
-
Urbana, Illinois, Förenta staterna, 61801
- CCOP - Carle Cancer Center
-
-
Iowa
-
Cedar Rapids, Iowa, Förenta staterna, 52403-1206
- CCOP - Cedar Rapids Oncology Project
-
Des Moines, Iowa, Förenta staterna, 50309-1016
- CCOP - Iowa Oncology Research Association
-
Sioux City, Iowa, Förenta staterna, 51101-1733
- Siouxland Hematology-Oncology
-
-
Kansas
-
Wichita, Kansas, Förenta staterna, 67214-3882
- CCOP - Wichita
-
-
Michigan
-
Ann Arbor, Michigan, Förenta staterna, 48106
- CCOP - Ann Arbor Regional
-
-
Minnesota
-
Duluth, Minnesota, Förenta staterna, 55805
- CCOP - Duluth
-
Rochester, Minnesota, Förenta staterna, 55905
- Mayo Clinic Cancer Center
-
Saint Cloud, Minnesota, Förenta staterna, 56303
- CentraCare Health Plaza
-
Saint Louis Park, Minnesota, Förenta staterna, 55416
- CCOP - Metro-Minnesota
-
-
Nebraska
-
Omaha, Nebraska, Förenta staterna, 68106
- CCOP - Missouri Valley Cancer Consortium
-
-
North Dakota
-
Bismarck, North Dakota, Förenta staterna, 58501
- Medcenter One Health System
-
Fargo, North Dakota, Förenta staterna, 58122
- CCOP - Merit Care Hospital
-
Grand Forks, North Dakota, Förenta staterna, 58201
- Altru Health Systems
-
-
Ohio
-
Toledo, Ohio, Förenta staterna, 43623-3456
- CCOP - Toledo Community Hospital
-
-
Pennsylvania
-
Danville, Pennsylvania, Förenta staterna, 17822-2001
- CCOP - Geisinger Clinic and Medical Center
-
Pittsburgh, Pennsylvania, Förenta staterna, 15212-4772
- Allegheny General Hospital
-
-
South Dakota
-
Rapid City, South Dakota, Förenta staterna, 57709
- Rapid City Regional Hospital
-
Sioux Falls, South Dakota, Förenta staterna, 57104
- CCOP - Sioux Community Cancer Consortium
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer
- Stage IIIB disease that is ineligible for combined modality therapy OR
- Stage IV disease
- Measurable disease
- No clinically detectable (by physical exam) third-space fluid collection (e.g., ascites or pleural effusions) that cannot be controlled by drainage or other procedures
- No brain metastases (even if treated)
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-1
Life expectancy:
- At least 12 weeks
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 9 g/dL
Hepatic:
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- AST and ALT no greater than 3 times ULN (5 times ULN if liver metastases present)
- Alkaline phosphatase no greater than 3 times ULN (5 times ULN if liver metastases present)
Renal:
- Creatinine clearance at least 45 mL/min
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Able to take folic acid or cyanocobalamin (vitamin B12) supplementation
- No uncontrolled infection
- No concurrent chronic debilitating disease
- No weight loss of 10% or more within the past 6 weeks
- No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or noninvasive carcinoma
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior biologic or genetic therapy for lung cancer
- No concurrent immunomodulating agents
Chemotherapy:
- No prior chemotherapy for lung cancer
Endocrine therapy:
- Not specified
Radiotherapy:
- At least 4 weeks since prior radiotherapy to a different site and recovered
- No prior radiotherapy to 25% or more of bone marrow
- No prior radiotherapy to whole pelvis
- No prior radiotherapy for primary disease
- No concurrent radiotherapy
Surgery:
- More than 4 weeks since prior major surgery
Other:
- No aspirin or nonsteroidal anti-inflammatory agents 2 days before, during, and for 2 days after pemetrexed disodium administration (5 days for long-acting agents such as piroxicam, naproxen, diflunisal, or nabumetone)
- No other concurrent cytostatic or cytotoxic therapy
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Arm I: pemetrexed + gemcitabine
Patients receive pemetrexed disodium IV over 10 minutes on day 1 followed by gemcitabine IV over 30 minutes on days 1 and 8.
|
|
|
Experimentell: Arm II: pemetrexed + gemcitabine
Patients receive gemcitabine IV over 30 minutes on days 1 and 8 followed by pemetrexed disodium IV over 10 minutes on day 1.
|
|
|
Experimentell: Arm III: pemetrexed + gemcitabine
Patients receive gemcitabine IV over 30 minutes on day 1 and pemetrexed disodium IV over 10 minutes followed by gemcitabine IV over 30 minutes on day 8.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
tumor response rate
Tidsram: Up to 4 years
|
Up to 4 years
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
duration of response
Tidsram: Up to 4 years
|
Up to 4 years
|
|
time to treatment failure
Tidsram: Up to 4 years
|
Up to 4 years
|
|
survival
Tidsram: Up to 4 years
|
Up to 4 years
|
|
time to disease progression
Tidsram: Up to 4 years
|
Up to 4 years
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Jatoi A, Hillman S, Stella P, Green E, Adjei A, Nair S, Perez E, Amin B, Schild SE, Castillo R, Jett JR; North Central Cancer Treatment Group. Should elderly non-small-cell lung cancer patients be offered elderly-specific trials? Results of a pooled analysis from the North Central Cancer Treatment Group. J Clin Oncol. 2005 Dec 20;23(36):9113-9. doi: 10.1200/JCO.2005.03.7465.
- An MW, Mandrekar SJ, Branda ME, Hillman SL, Adjei AA, Pitot HC, Goldberg RM, Sargent DJ. Comparison of continuous versus categorical tumor measurement-based metrics to predict overall survival in cancer treatment trials. Clin Cancer Res. 2011 Oct 15;17(20):6592-9. doi: 10.1158/1078-0432.CCR-11-0822. Epub 2011 Aug 31.
- Campbell ME, Mandrekar SJ, Hillman SL, et al.: What is the added value of actual tumor measurements (TM) in predicting overall survival (OS)? The North Central Cancer Treatment Group (NCCTG) findings. [Abstract] J Clin Oncol 26 (Suppl 15): A-6520, 2008.
- Adjei AA, Salavaggione OE, Mandrekar SJ, Dy GK, Ziegler KL, Endo C, Molina JR, Schild SE, Adjei AA. Correlation between polymorphisms of the reduced folate carrier gene (SLC19A1) and survival after pemetrexed-based therapy in non-small cell lung cancer: a North Central Cancer Treatment Group-based exploratory study. J Thorac Oncol. 2010 Sep;5(9):1346-53. doi: 10.1097/JTO.0b013e3181ec18c4.
- Ma CX, Nair S, Thomas S, Mandrekar SJ, Nikcevich DA, Rowland KM, Fitch TR, Windschitl HE, Hillman SL, Schild SE, Jett JR, Obasaju C, Adjei AA; North Central Cancer Treatment Group; Mayo Clinic; Eli Lilly & Company. Randomized phase II trial of three schedules of pemetrexed and gemcitabine as front-line therapy for advanced non-small-cell lung cancer. J Clin Oncol. 2005 Sep 1;23(25):5929-37. doi: 10.1200/JCO.2005.13.953.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 augusti 2001
Primärt slutförande (Faktisk)
1 november 2003
Avslutad studie (Faktisk)
1 oktober 2008
Studieregistreringsdatum
Först inskickad
10 augusti 2001
Först inskickad som uppfyllde QC-kriterierna
26 januari 2003
Första postat (Uppskatta)
27 januari 2003
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
7 december 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
5 december 2016
Senast verifierad
1 december 2016
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Luftvägssjukdomar
- Neoplasmer
- Lungsjukdomar
- Neoplasmer efter plats
- Neoplasmer i andningsvägarna
- Thoracic neoplasmer
- Karcinom, bronkogent
- Bronkiella neoplasmer
- Lungneoplasmer
- Karcinom, icke-småcellig lunga
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Anti-infektionsmedel
- Antivirala medel
- Nukleinsyrasynteshämmare
- Enzyminhibitorer
- Antimetaboliter, antineoplastiska
- Antimetaboliter
- Antineoplastiska medel
- Immunsuppressiva medel
- Immunologiska faktorer
- Folsyraantagonister
- Gemcitabin
- Pemetrexed
Andra studie-ID-nummer
- NCCTG-N0026
- NCI-2012-02399 (Registeridentifierare: CTRP (Clinical Trials Reporting System))
- CDR0000068838 (Registeridentifierare: PDQ (Physician Data Query))
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .