Status:
TERMINATED
Individualized Drug Treatment for Treating Patients With Pancreatic Cancer
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Treating tumor tissue in the laboratory with different drugs may help doctors find the best drug for treating individual patients with pancreatic cancer. PURPOSE: This phase II trial is st...
Detailed Description
OBJECTIVES: * Establish tumor xenografts from patients with resectable adenocarcinoma of the pancreas who undergo surgical resection at Johns Hopkins Hospital. * Determine the activity of a series of...
Eligibility Criteria
Inclusion
- Part A
- Inclusion Criteria
- Suspected adenocarcinoma of the pancreas with resectable disease schedule to have surgical resection at the Johns Hopkins Hospital.
- Age ≥ 18 years old.
- Ability to understand and willingness to sign a written informed consent document.
- Part B
- Inclusion Criteria
- Participation in Part A of the study with informative mouse xenograft data.
- Histologically or cytologically confirmed diagnosis of invasive adenocarcinoma of the pancreas and peripancreatic adenocarcinoma, including distal cholangiocarcinoma, duodenal carcinoma, and ampullary pancreatic not amenable to curative treatment.
- ECOG performance status 0 or 1
- Age ≥ 18 years old.
- Expected survival \> 12 weeks.
- No prior treatment for recurrent disease.
- Willingness of male and female subjects, who are not surgically sterile or postmenopausal, to use reliable methods of birth control (oral contraceptives, intrauterine devices, or barrier methods used with a spermicide) for the duration of the study and for 30 days after the last dose of test article.
- Adequate liver, renal and bone marrow functions.
- WBC \> 3,500 cells/mm3 ANC \> 1,500 cells/mm3 Platelets \> 100,000 cells/mm3 Hemoglobin ≥ 9 g/dl Serum creatinine 2 mg/dl Bilirubin 2 mg/dL ALT, AST, and alkaline phosphatase 5 times the upper limit of normal
- Exclusion criteria
- Patients in whom histologic or cytologic diagnosis is not consistent with adenocarcinoma.
- Patients in whom histologic or cytologic diagnosis is consistent with non epithelial origin tumors, including adenosquamous, islet cell, cystadenoma or cystadenocarcinoma, carcinoid, small or large cell carcinoma, sarcoma, lymphoma and melanoma
- Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- 4\. Patients who have had any previous surgery, excluding minor procedures, dental work, skin biopsy, etc. within 4 weeks of enrollment.
- 5\. Uncontrolled medical conditions that could potentially increase the risk of toxicities or complications when treated with chemotherapy. Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease.
- 6\. Active infections.
- 7\. History of another neoplasm except for non-metastatic, nonmelanoma skin cancers, \< 5 years prior to enrollment.
- 8\. Unable to provide informed consent.
- 9\. Treatment with chemotherapy within 30 days of day 1 treatment.
- 10\. Any unresolved chronic toxicity greater than CTCAE grade 2 from previous anticancer therapy (except alopecia).
- 11\. Pregnant women are excluded from this study because the effects of the chemotherapy agents to be tested on the developing fetus are not known. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with MMC, breast feeding should be discontinued if the mother is treated with the drug.
- 12\. Patients must not have documented history of clinically significant cardiovascular disease including myocardial infarction (within 12 months prior to randomization), unstable angina, grade II or greater peripheral vascular disease, uncontrolled congestive heart failure or uncontrolled hypertension (SBP\>170, DBP\>95).
- 13\. Patients with non informative xenograft data including patients whose tumors do not take in the mice, who progress before mice data is available or whose tumors do not respond to any of the selected agents.
Exclusion
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
249 Patients enrolled
Trial Details
Trial ID
NCT00276744
Start Date
October 1 2005
End Date
April 1 2010
Last Update
October 24 2018
Active Locations (1)
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1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410