Status:
COMPLETED
External-Beam Radiation Therapy, Capecitabine, and Sorafenib in Treating Patients With Locally Advanced Rectal Cancer
Lead Sponsor:
Swiss Cancer Institute
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing ...
Detailed Description
OBJECTIVES: * Determine the recommended dose of neoadjuvant capecitabine when given together with sorafenib tosylate and external-beam radiotherapy in patients with K-ras mutated, locally advanced re...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed locally advanced adenocarcinoma of the rectum (with or without nodal involvement) requiring surgery
- Stage mrT3-4, and/or mrN1-2, M0 disease
- Tumor with K-ras gene mutation as assessed locally
- No distant metastases
- PATIENT CHARACTERISTICS:
- WHO performance status 0-1
- Neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hemoglobin ≥ 10.0 g/dL
- Creatinine clearance ≥ 50mL/min
- AST ≤ 2.5 times upper limit of normal (ULN)
- Total bilirubin ≤ 1.5 times ULN
- PT/INR or PTT ≤ 1.5 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception during and for 12 months after completion of study therapy
- Is compliant and geographic proximity allows for proper staging and follow-up
- No other malignancy within the past 5 years except adequately treated cervical carcinoma in situ or localized nonmelanoma skin cancer
- No psychiatric disorder that would preclude understanding study-related information, giving informed consent, or complying with oral drug intake
- No clinically significant (i.e., active) cardiac disease (e.g., congestive heart failure, symptomatic coronary artery disease, or cardiac arrhythmia \[even if controlled with medication\]) or myocardial infarction within the past 12 months
- No uncontrolled hypertension
- No evidence or history of bleeding diathesis
- No lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome
- No serious or underlying condition (e.g., active autoimmune disease, uncontrolled diabetes, or uncontrolled infection) that, in the judgement of the investigator, could preclude the ability of the patient to participate in the study
- No known hypersensitivity to study drugs or to any other component of the study drugs
- PRIOR CONCURRENT THERAPY:
- No prior treatment for rectal cancer
- No prior organ allografts
- More than 4 weeks since prior major surgery other than colostomy
- More than 30 days since prior treatment in a clinical trial
- No other concurrent experimental drugs or anticancer therapy
- No concurrent brivudine, lamivudine, ribavirin, or any other nucleoside analogue
- No concurrent drugs contraindicated for use with the study drugs
- No other concurrent radiotherapy
- No concurrent anticoagulation therapy other than low molecular weight heparin
Exclusion
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00869570
Start Date
March 1 2009
End Date
September 1 2016
Last Update
May 15 2019
Active Locations (18)
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1
Szent Laszlo Korhaz
Budapest, Hungary, 1097
2
Saint Claraspital AG
Basel, Switzerland, CH-4016
3
Universitaetsspital-Basel
Basel, Switzerland, CH-4031
4
Istituto Oncologico della Svizzera Italiana - Ospedale Regionale Bellinzona e Valli
Bellinzona, Switzerland, 6500