MDACC Study Summary 2007-0014

Study Summary
No. 2007-0014:.......Pancreas......James L. Abbruzzese......Gastrointestinal Medical Oncology

Study Summary Title



Study Summary Number:	2007-0014

Study Title:	Phase II Trial of Novasoy, Gemcitabine, and Erlotinib in Locally Advanced or Metastatic Pancreatic Cancer (2005-006)

Physician

New Patient Referral



Name:	James L. Abbruzzese	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Gastrointestinal Medical Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-2828 Contact us about clinical trials

General Information



Disease Group:	Pancreas	Supported By:	Karmanos Cancer Center, Wayne State University OSI Pharmaceuticals (Supporter)

Phase of Study:	Phase II	Return Visit:	Days 1, 8, & 15 of each 28 day cycle.

Treatment Agents:	Erlotinib Gemcitabine Novasoy	Home Care:	Patients may take erlotinib and Novasoyâ at home as these are oral medications.

Treatment Loc:	Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	Hospitalization is not required for this study.


Description/ Intervention:	The goal of this clinical research study is to learn if the combination of Novasoỷ, gemcitabine, and erlotinib hydrochloride can help to control advanced pancreatic cancer. The safety of this treatment will also be studied.

Study Objectives / Outcomes

Primary Objectives:

To determine the six-month survival of patients with metastatic or locally advanced pancreatic cancer treated with the combination of gemcitabine, erlotinib and Novasoy^â

Secondary Objectives:

To determine the frequency of objective tumor response rate.
To determine time to treatment failure.
To determine the effect of baseline expression of pAKT and activation of nuclear factor kappa B (NF-kB) on survival of patients with pancreatic cancer treated with the study drugs.
To obtain data on the overall time to disease progression.
To estimate the quantitative and qualitative toxicities of the regimen.

Study Status Information



Study Activation / Registration Date:	07/24/2007

IRB Review and Approval Date:	04/20/2007

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Closed

Projected Accrual:	40

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Patients must have histologic or cytologic diagnosis of pancreatic adenocarcinoma with radiological evidence of locally advanced or metastatic disease.

2) Patient must be at least 21 years of age (this disease is rarely seen in patients younger than 21).

3) Patients must not have received prior chemotherapy or radiation for metastatic disease. Prior adjuvant or neoadjuvant chemotherapy and/or radiation is allowed, provided that the last day of therapy was at least 6 months prior to registration.

4) Patients must have performance status of 0-1 on the SWOG scale.

5) Patients must have adequate bone marrow function: absolute neutrophil count >/= 1, 500/cmm, platelet count >/=100,000/cmm.

6) Both the patient and their sexual partner must be willing to practice birth control if the female has reproductive capability.

7) Patients must be informed of the investigational nature of this study and must give written informed consent prior to the receiving of treatment per this protocol.

Exclusion Criteria:

1) Patients with endocrine tumors or lymphoma of the pancreas.

2) History of central nervous system (CNS) metastases.

3) Liver dysfunction, bilirubin >/= 2.0 mg/dL; aspartate transaminase (AST) and alanine amino transferase (ALT) >/= 1.5 times upper limit of institutional normal.

4) Creatinine >/= 1.5 g/dL.

5) Albumin </= 2.5 g/dL.

6) INR>/= 1.5 (in the absence of ongoing treatment with warfarin).

7) Breast-feeding.

8) Serious active infection.

9) Any condition that would limit the ability to receive oral medication (i.e. erlotinib, Novasoy). Administration of drugs through a g-tube will not be allowed.

10) Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator).

11) Active second primary malignancy (except in situ carcinoma of the cervix, or adequately treated basal cell carcinoma of the skin) within less than one year of enrollment into this study.

12) Prior treatment with gemcitabine or EGFR inhibiting agents.

13) Allergy to study medications.

Links

Registration Number: NCT00376948
Study Information on Clinical Trials Registry (clinicaltrials.gov)