Irinotecan or Fluorouracil Plus Leucovorin in Treating Patients With Previously Treated Metastatic Colorectal Cancer
Phase II Study in Patients With Metastatic Colorectal Carcinoma Previously Treated With Oxaliplatin (OXAL) or a Combination of Irinotecan (CPT-11) and OXAL
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more tumor cells.
PURPOSE: Phase II trial to compare the effectiveness of either irinotecan or fluorouracil plus leucovorin in treating patients who have metastatic colorectal cancer that has been previously treated with oxaliplatin with or without irinotecan.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
OBJECTIVES:
- Determine the tumor response rate in patients receiving irinotecan or fluorouracil and leucovorin calcium for metastatic colorectal cancer previously treated with oxaliplatin with or without irinotecan.
- Determine the time to tumor progression, time to treatment failure, and overall survival of patients treated with these regimens.
- Determine the toxic effects of these regimens in these patients.
- Evaluate the quality of life of patients treated with these regimens.
OUTLINE: This is a multicenter study. Patients are stratified according to prior chemotherapy (oxaliplatin-based therapy vs irinotecan and oxaliplatin combination therapy). Patients are assigned to one of two treatment groups.
- Group I (prior oxaliplatin-based chemotherapy): Patients receive irinotecan IV over 90 minutes on day 1. Treatment repeats every 3 weeks.
- Group II (prior irinotecan and oxaliplatin combination chemotherapy): Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV continuously on days 1 and 2. Treatment repeats every 2 weeks.
- Both groups: Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with a confirmed complete response for 2 consecutive courses may discontinue treatment at investigator's discretion.
Quality of life is assessed at baseline, approximately every 6 weeks during treatment, and then after the last course of treatment.
Patients are followed every 3 months for 5 years.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
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
-
Rochester, Minnesota, Förenta staterna, 55905
- Mayo Clinic Cancer Center
-
Saint Louis Park, Minnesota, Förenta staterna, 55416
- CCOP - Metro-Minnesota
-
-
Nebraska
-
Omaha, Nebraska, Förenta staterna, 68106
- CCOP - Missouri Valley Cancer Consortium
-
-
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
-
-
-
-
Saskatchewan
-
Regina, Saskatchewan, Kanada, S4T 7T1
- Allan Blair Cancer Centre
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
DISEASE CHARACTERISTICS:
- Diagnosis of metastatic colorectal adenocarcinoma incurable by surgery or not amenable to radiotherapy with curative intent
Progressive disease after one of the following prior treatments for metastatic disease:
- Oxaliplatin-based chemotherapy
- Irinotecan and oxaliplatin combination chemotherapy
At least 1 measurable lesion
- At least 20 mm in at least one dimension
- No known CNS metastases or carcinomatous meningitis
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- At least 12 weeks
Hematopoietic:
- Absolute neutrophil count at least 2,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 0.5 mg/dL above upper limit of normal (ULN)
- AST no greater than 5 times ULN
Renal:
- Creatinine no greater than 1.5 times ULN
Cardiovascular:
- No unstable angina
- No symptomatic congestive heart failure
- No serious uncontrolled cardiac arrhythmia
Other:
- No active or uncontrolled infection
- No evidence of other serious illness
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or noninvasive carcinomas
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent sargramostim (GM-CSF)
Chemotherapy:
- See Disease Characteristics
- At least 4 weeks since prior chemotherapy
- No more than 1 prior chemotherapy regimen for advanced colorectal cancer
- Prior adjuvant chemotherapy allowed
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
- No prior radiotherapy to more than 25% of bone marrow
Surgery:
- See Disease Characteristics
- At least 4 weeks since prior major surgery
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: irinotecan
Prior oxaliplatin-based chemotherapy: Patients receive irinotecan IV over 90 minutes on day 1. Treatment repeats every 3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with a confirmed complete response for 2 consecutive courses may discontinue treatment at investigator's discretion. Quality of life is assessed at baseline, approximately every 6 weeks during treatment, and then after the last course of treatment. Patients are followed every 3 months for 5 years. |
|
|
Experimentell: leucovorin + fluorouracil
Prior to irinotecan and oxaliplatin combination chemotherapy: Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV continuously on days 1 and 2. Treatment repeats every 2 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with a confirmed complete response for 2 consecutive courses may discontinue treatment at investigator's discretion. Quality of life is assessed at baseline, approximately every 6 weeks during treatment, and then after the last course of treatment. Patients are followed every 3 months for 5 years. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
tumörsvarsfrekvens
Tidsram: Upp till 5 år
|
Upp till 5 år
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
total överlevnad
Tidsram: Upp till 5 år
|
Upp till 5 år
|
|
livskvalité
Tidsram: Upp till 5 år
|
Upp till 5 år
|
|
time to tumor progression
Tidsram: Up to 5 years
|
Up to 5 years
|
|
tid till behandlingsmisslyckande
Tidsram: Upp till 5 år
|
Upp till 5 år
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Studiestol: Henry C. Pitot, MD, Mayo Clinic
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
- Gastrointestinala neoplasmer
- Neoplasmer i matsmältningssystemet
- Gastrointestinala sjukdomar
- Kolonsjukdomar
- Tarmsjukdomar
- Intestinala neoplasmer
- Rektala sjukdomar
- Kolorektala neoplasmer
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Enzyminhibitorer
- Antimetaboliter, antineoplastiska
- Antimetaboliter
- Antineoplastiska medel
- Immunsuppressiva medel
- Immunologiska faktorer
- Skyddsmedel
- Topoisomerasinhibitorer
- Mikronäringsämnen
- Vitaminer
- Kalciumreglerande hormoner och medel
- Topoisomeras I-hämmare
- Motgift
- Vitamin B-komplex
- Fluorouracil
- Leucovorin
- Irinotekan
- Kalcium
- Levoleucovorin
Andra studie-ID-nummer
- NCCTG-N0048
- NCI-2012-02383 (Registeridentifierare: CTRP (Clinical Trials Reporting System))
- CDR0000068635 (Registeridentifierare: PDQ (Physician Data Query))
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