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Active Clinical Trials > Cancer Treatment and Symptom Management Trials |
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Active Clinical Trials: Gallbladder
| Protocol | Title |
S0941 (GI- Gallbladder) | Phase II Study of Sorafenib (NSC-724772) and Erlotinib (NSC-718781) in Patients with Advanced Gallbladder Carcinoma or Cholangiocarcinoma (1805)-
Eligibility: click to view information
DISEASE CHARACTERISTICS:
Cytologically or pathologically confirmed gallbladder carcinoma or cholangiocarcinoma
No ampullary carcinoma
Locally advanced unresectable or distant metastatic disease
Measurable disease
Patients with biliary obstruction must have decompression of the biliary tree by ERCP and stenting or percutaneous drainage
No prior systemic treatment for metastatic or unresectable locally advanced disease
No known brain metastases
PATIENT CHARACTERISTICS:
Zubrod performance status of 0-1
Leukocyte count = 3,000/mm^3
ANC = 1,000/mm^3
Platelet count = 100,000/mm^3
Total serum bilirubin = 1.5 times upper limit of normal (ULN)
For patient who had decompression of the biliary tree within the past 14 days, stability of the bilirubin level needs to be confirmed with two measurements within 5 to 7 days of each other
Serum albumin = 2.5 g/dL
AST and ALT = 2.5 times ULN (= 5 times ULN for liver metastases)
Creatinine clearance = 60 mL/min
Not pregnant or nursing
Fertile patients must agree to use effective contraception
No active biliary sepsis
No bleeding diathesis
No uncontrolled or clinically significant cardiovascular disease, including any of the following:
Myocardial infarction within the past 6 months
Uncontrolled angina within the past 6 months
NYHA class II-IV congestive heart failure
Grade 3 cardiac valve dysfunction
Cardiac arrhythmia not controlled by medication
History of stroke or transient ischemic attack within the past 6 months
History of arterial thrombotic event of any type in the past 6 months
No uncontrolled hypertension, as evidenced by systolic BP = 150 mm Hg or diastolic BP = 100 mm Hg, within the past 28 days
Must be able to swallow and tolerate oral medications
No gastrointestinal tract disease or prior abdominal surgery that results in an inability to absorb oral medication
No other prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free within the past 3 years
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
At least 6 months since 1 adjuvant or neoadjuvant regimen of chemotherapy, hormonal therapy, immunotherapy, radiotherapy (to < 25% of bone marrow only), or chemoradiotherapy prior to documented recurrence or metastatic disease
No prior treatment with any anti-angiogenic agent or any EGFR inhibitors for any reason
Concurrent multiple anti-hypertensive medications allowed
No plans to receive concurrent chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or any other therapy, including herbal or alternative medications for treatment of cancer
No concurrent grapefruit or its juice
- Consent Forms: S0941 Consent
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SWOG-S0809 (GI- Gallbladder) | A Phase II Trial of Adjuvant Capecitabine/Gemcitabine Chemotherapy Followed by Concurrent Capecitabine and Radiotherapy in Extrahepatic Cholangiocarcinoma (EHCC). (1652)-
Eligibility: click to view information
DISEASE CHARACTERISTICS:
Histopathologically confirmed extrahepatic cholangiocarcinoma of the gallbladder or bile duct, meeting at least 1 of the following criteria:
Pathological T2-4 disease
Pathological N1 disease
Positive margins (any T or N )
Must have undergone potentially curative radical resection with negative (R0) or microscopically positive (R1) margins within the past 56 days and recovered
No distant metastatic disease as indicated by a CT scan or MRI of the chest, abdomen, and pelvis within the past 42 days
Positive resected regional lymph nodes allowed
No ampullary cancer
PATIENT CHARACTERISTICS:
Zubrod performance status 0-1
ANC > 1,500/¼L
Platelet count > 100,000/¼L
Serum creatinine < 1.5 mg/dL
Total bilirubin < 1.5 times upper limit of normal (ULN)
SGOT or SGPT < 2.5 times ULN
Not pregnant or nursing
Fertile patients must use effective contraception
Able to swallow enteral medications and no requirement for a feeding tube
No intractable nausea or vomiting
No gastrointestinal (GI) tract disease resulting in an inability to take oral medication, malabsorption syndrome, requirement for IV alimentation, prior surgical procedures affecting absorptions. or uncontrolled inflammatory GI disease (e.g., Crohn disease, ulcerative colitis)
No uncontrolled intercurrent illness including but not limited to any of the following:
Ongoing or active infection
Symptomatic congestive heart failure
Unstable angina pectoris
Cardiac arrhythmia
Myocardial infarction or cerebrovascular accident within the past 3 months
Uncontrolled diarrhea
Psychiatric illness or social situations that would limit compliance with study requirements
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
No prior chemotherapy or radiotherapy for this disease
No prior upper abdominal radiotherapy
- Consent Forms: S0809 Consent
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