Status and phase
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About
RATIONALE: Drugs used in chemotherapy, such as capecitabine and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy, monoclonal antibody therapy, and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II trial is studying the side effects of giving capecitabine and panitumumab together with radiation therapy with or without irinotecan hydrochloride and to see how well it works in treating patients undergoing surgery for localized rectal cancer.
Full description
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients undergo surgery 6-8 weeks after completion of chemoradiotherapy,
After completion of study treatment, patients are followed up every 3 months for 1 year and then every 6 months thereafter.
Enrollment
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Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the distal rectum (0-9 cm from the dentate line or 3-12 cm from the anal verge)
T3 or T4 tumor or nodal involvement by endorectal ultrasound or CT scan or MRI
No known homozygotes to UGT1A1* 28
No distant metastases
PATIENT CHARACTERISTICS:
ECOG performance status 0-1
ANC ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
ALT and AST ≤ 3 times ULN
Serum creatinine ≤ 1.5 times ULN
Creatinine clearance ≥ 50 mL/min
Magnesium normal
Able to tolerate major surgery
Able and willing to comply with study requirements
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 4 weeks (males) or 24 weeks (females) after completion of study therapy
No prior diagnosis of interstitial lung disease
No prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to fluorouracil
No other prior or concurrent invasive malignancy unless disease-free for ≥ 5 years
No lack of physical integrity of the upper gastrointestinal tract, inability to swallow tablets, or malabsorption syndrome
No concurrent serious infections
No clinically significant cardiovascular disease within the past year, including any of the following:
No history of any medical or psychiatric condition or laboratory abnormality that, in the opinion of the investigator, may increase risks associated with study participation or investigational product(s) administration or may interfere with the interpretation of the study results
No known positivity for HIV, hepatitis C, or acute or chronic active hepatitis B
PRIOR CONCURRENT THERAPY:
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Data sourced from clinicaltrials.gov
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