MDACC Study Summary 2005-0823

Study Summary
No. 2005-0823:.......Lung......William N. William Jr.......Thoracic and Head and Neck Med

Study Summary Title



Study Summary Number:	2005-0823

Study Title:	A Biomarker-integrated study in Chemorefractory Patients with Advanced Non-Small Cell Lung Cancer

Physician

New Patient Referral



Name:	William N. William Jr.	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Thoracic and Head and Neck Med	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-6363 Contact us about clinical trials

General Information



Disease Group:	Lung	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	Patients who meet the eligibility criteria will be enrolled into the BATTLE Trial. After having a tumor biopsy and profiling of biomarkers, patients will be randomized into one of four biomarker-integrated trials. Return visits vary per protocol.

Treatment Agents:	None	Home Care:	N/A

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this screening study to find out if you are eligible to take part in 1 of 4 different treatment studies.

Study Objectives / Outcomes

This trial is referred to as the "umbrella trial". The BATTLE program consists of this umbrella trial plus four phase II protocols into which the umbrella patients are enrolled. Patients will first enroll in the BATTLE umbrella trial and undergo a tumor biomarker analysis that will be used to assign them to one of the four phase II studies. All patients enrolled in one of the phase II BATTLE protocols must be enrolled in this protocol.

The primary objective of each of the phase II studies will be:

Primary Objectives

• To determine the 8-week progression-free survival rate (i.e. disease control rate) in patients with advanced NSCLC who have failed at least one prior chemotherapy regimen.

Secondary Objectives

• Determine the overall response rate

• Determine the overall survival

• Determine the time to disease progression

• Assess the safety/toxicity of the study treatment(s)

• Assess biomarker modulation in the tumor tissue and serum samples from the treatment

• Assess plasma and intra-tumor concentrations of study treatment

Study Status Information



Study Activation / Registration Date:	11/27/2006

IRB Review and Approval Date:	04/04/2006

Study Type:	Other

Recruitment Status:	Closed

Projected Accrual:	250 participants; We will screen approximately 328 patients in order to accrue 250 randomized patients. We propose to randomize a total of 250 patients with the goal of reaching 200 fully evaluable patients. The "fully evaluable" patients are defined as patients with full biomarker profile assessed and evaluable for the primary endpoint of 8-week disease status.

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) The patient has a diagnosis of pathologically confirmed NSCLC by tumor biopsy and/or fine-needle aspiration

2) The patient has a diagnosis of either stage IIIB, stage IV, or advanced, incurable NSCLC, and failed at least one front-line metastatic NSCLC chemotherapy regimen. (Patients who have failed adjuvant or locally advanced therapy within 6 months are also eligible to participate in study).

3) The patient has uni-dimensionally measurable NSCLC.

4) Karnofsky performance status >/= 60 or ECOG performance status 0-2

5) The patient has biopsy accessible tumor.

6) The patient has adequate hematologic function as defined by an absolute neutrophil count (ANC) >/= 1,500/mm^3, platelet count >/= 100,000/mm^3, WBC >/= 3,000/ mm^3, and hemoglobin >/= 9 g/dL.

7) The patient has adequate hepatic function as defined by a total bilirubin level </= 1.5 X the upper limit of normal, and alkaline phosphatase, AST or ALT </= 2.5 X the upper limit of normal.

8) The patient has adequate renal function as defined by a serum creatinine level </= 1.5 mg/dL or a calculated creatinine clearance of >/= 60cc/minute.

9) The patient has PT < 1.5 x upper limit of normal

10) If patient has brain metastasis, they must have been stable (treated or asymptomatic) for at least 4 weeks after radiation if treated with radiation and not have used steroids for at least 1 week. Re-imaging performed after 2 weeks, upon completion of radiation therapy.

11) The patient is >/= 18 years of age.

12) The patient has signed informed consent.

13) The patient is eligible if disease free from a previously treated malignancy, other than a previous NSCLC, for greater than two years. Patients with a history of prior basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix are exempt from exclusion.

14) Women of childbearing potential 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. Childbearing potential will be defined as women who have had menses within the past 12 months,who have not had tubal ligation or bilateral oophorectomy.Should a woman become pregnant or suspect that she is pregnant while participating in this study,she should inform her treating physician immediately.The patient,if a man,agrees to use effective contraception or abstinence.

15) Subject must be considered legally capable of providing his or her own consent for participation in this study.

Exclusion Criteria:

1) The patient has received prior investigational therapy, chemotherapy, surgery, or radiotherapy within 4 weeks of initiating study drug

2) The patient has undergone prior thoracic or abdominal surgery within 28 days of study entry, excluding prior diagnostic biopsy.

3) The patient has received radiation therapy to the measurable tumor within 6 months. Patients are allowed to have local irradiation for the management of tumor-related symptoms (bones, brain). However, if a patient has active new disease growing in the previously irradiated site, the patient will be eligible to participate in the study.

4) The patient has a significant medical history or unstable medical condition (unstable systemic disease: congestive heart failure (New York Heart Association Functional Classification class II or worse), recent myocardial infarction within 3 months, unstable angina, active infection (i.e. currently treated with antibiotics), uncontrolled hypertension). Patients with controlled diabetes will be allowed. Patient must be able to undergo procedure for tissue acquisition.

5) The patient has uncontrolled seizure disorder, active neurologic disease, or neuropathy >/= grade 2. Patients with meningeal or CNS involvement by tumor are eligible for the study if the above exclusion criteria are not met.

6) The patient is pregnant (confirmed by serum Beta-HCG if applicable) or is breastfeeding.

7) Any condition that is unstable or could jeopardize the safety of the patient and its compliance in the study, in the investigator's judgment.

8) The patient is actively taking herbal remedies or over-the-counter biologics (e.g., shark cartilage, high dose antioxidants).

9) Patients will be allowed to have prior biologic (i.e. VEGF, EGFR, etc.) therapy. However, the patient will be excluded from a given study if he/she has received the same therapy as the clinical trial (i.e. If a patient has been previously treated with bevacizumab, they are allowed to enroll in any of the 4 studies. If a patient has been previously treated with erlotinib, they are excluded from the clinical trials with erlotinib). In addition, if a patient has been previously treated with gefitinib (Iressa), they are excluded from the clinical trials with erlotinib.

Links

Registration Number: NCT00409968
Study Information on Clinical Trials Registry (clinicaltrials.gov)