Individualized Drug Treatment for Treating Patients With Pancreatic Cancer

Stopped early · Phase 2

Conditions studied: Pancreatic Cancer

In brief

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 studying an individualized drug treatment selection process, based on laboratory results, for treating patients with pancreatic cancer that can be removed by surgery.

Key facts

Study ID

NCT00276744

Run by

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

People needed

249

Starts

2005-10-01

Expected to finish

2010-04-01

Last updated by the study team

2018-10-24

Who can join

Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.
• Patients who have had any previous surgery, excluding minor procedures, dental work, skin biopsy, etc. within 4 weeks of enrollment.
• 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.
• Active infections.
• History of another neoplasm except for non-metastatic, nonmelanoma skin cancers, < 5 years prior to enrollment.
• Unable to provide informed consent.
• Treatment with chemotherapy within 30 days of day 1 treatment.
• Any unresolved chronic toxicity greater than CTCAE grade 2 from previous anticancer therapy (except alopecia).
• 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.
• 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).
• 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.

Where it is running

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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