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Details for trial 3P-09-1

Description:	Phase II Study of Gemcitabine and Intermittent Erlotinib in Advanced Pancreatic Cancer.
Status:	Open
Randomized?	No

Researchers

Principal Investigator	Title
Heinz Josef Lenz	M.D.

Data Management

Name	Title
Ramona Lujan	R.N.
Jiayi Jiang	D.M.
Noureddine Miloud	D.M.
Carol Jones	R.N.

You may participate in this study if:

	Requirement
1	Histologically or cytologically confirmed locally advanced, metastatic or recurrent pancreatic carcinoma.
2	Must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as greater than or equal to 20 mm with conventional techniques, or as greater than 10 mm with spiral CT scan.
3	No prior chemotherapy for metastatic or recurrent disease is allowed. Prior adjuvant chemotherapy is allowed, provided that patients did not receive gemcitabine and the chemotherapy was completed > six months prior to initiation of study therapy. Prior erlotinib therapy is not allowed.
4	Available tumor specimen that was obtained at the time of diagnosis and/or prior to study entry is highly encouraged.
5	Age greater than or equal to 18 years. Pancreatic cancer is a disease of adults.
6	Life expectancy greater than 3 months.
7	Zubrod performance status less than or equal to 2.
8	Patients must have normal organ and marrow function as defined below: -leukocytes greater than or equal to 3,000 -absolute neutrophil count greater than or equal to 1,500 -platelets greater than or equal to 100,000 -total bilirubin less than or equal to 1.5 X institutional upper limit of normal -- A ST(SGOT)/ALT(SGPT) less than or equal to 3 X institutional upper limit of normal, unless the liver is involved with tumor, in which case the AST/ALT must be less than or equal to 5 X institutional upper limit of normal -- creatinine clearance greater than or equal to 50 as measured by 24 hours collection OR creatinine less than or equal to 1.5 X institutional upper limit of normal.
9	The effects of erlotinib and gemcitabine on the developing human fetus at the recommended therapeutic doses are unknown. For this reason, and because other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
10	Ability to understand and the willingness to sign a written informed consent document.

You may not participate in this study if:

1	Patients may not be receiving any other investigational agents.
2	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.
3	History of allergic reactions attributed to compounds of similar chemical or biologic composition to berlotinib or gemcitabine.
4	Secondary primary malignancy (except in situ carcinoma or adequately treated nonmelanomatous carcinoma of the skin or other malignancy treated at least 5 years previously with no evidence of previous recurrence). Concurrent or history of another malignancy < 5 years.
5	Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled hypertension, or psychiatric illness/social situations that would limit compliance with study requirements.
6	Pregnant women are excluded from this study because erlotinib and gemcitabine have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with erlotinib or gemcitabine, breastfeeding should be discontinued if the mother is treated with study drugs.
7	Patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy. Therefore, HIV-positive patients and those receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with the study drugs.

For further information on, or to sign up for this study, please contact the Clinical Investigation Support Office at (323) 865-0451 or the Principal Investigator noted above.