Study of Treatment With Gemcitabine v. Tarceva v. Gemcitabine & Tarceva in Elderly Patients With NSCLC

Condition(s) targeted: Non-Small Cell Lung Cancer

Intervention: Gemcitabine (Drug); Tarceva (Drug); Gemcitabine and Tarceva (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: UNC Lineberger Comprehensive Cancer Center

Official(s) and/or principal investigator(s):
Mark A Socinski, MD, Principal Investigator, Affiliation: University of North Carolina

Overall contact:
Maureen Tynan, RN, OCN, Phone: 919-966-4432, Email: tynanm@med.unc.edu

Patients to be enrolled on this study are 70 years old or older and have advanced or metastatic non-small cell lung cancer. Chemotherapy may be used to relieve symptoms but is not curative.

Patients who are 70 years old or older make up 30% of all lung cancer patients. Treatments for this subgroup of patients have not been well defined and results may differ from younger patient populations. For that reason, this study is being limited to the 70 years old or older age group.

The treatment received in this study consists of two drugs, gemcitabine and erlotinib. Gemcitabine is an active agent in the treatment of NCSLC and has shown to improve survival as a single agent. Gemcitabine is approved by the FDA for use in metastatic non-small cell lung cancer. Erlotinib is a drug that has shown promising activity against a number of types of cancer. Erlotinib is a new treatment that has been shown to slow or stop growth in tumors, including non-small cell lung cancer. Because erlotinib works differently from the way other chemotherapy drugs work, researchers believe that combining the gemcitabine and erlotinib may have added benefit. Recent studies have shown that erlotinib may work better in some people with a certain mutation in their tumor cells. For that reason, we would like to request some tumor samples to see if this mutation is present. This part of the study is optional. The purpose of the study is to observe the response to treatment in elderly patients with stage IIIB/IV non-small cell lung cancer treated with the combination of weekly gemcitabine and erlotinib.

Official title: LCCC 0512 - Randomized Phase II Study of First-Line Treatment With Gemcitabine vs. Erlotinib vs. Gemcitabine and Erlotinib in Elderly Patients With Stage IIIB/IV Non-Small Cell Lung Cancer

Study design: Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: To estimate the progression free survival rates of elderly patients treated with single agent gemcitabine, erlotinib, or the combination.

Secondary outcome:

To estimate the response rates of elderly patients treated on the three arms.

To estimate the overall survival rates of patients treated on the three arms.

To observe the toxicity profile on the three arms.

To observe the quality of life on the three arms.

To collect tumor and blood samples of patients entered on this trial for future analysis of correlation between molecular markers and clinical benefit.

Detailed description: This is a Phase II trial in elderly patients (≥70 years old) with stage IIIB/IV non-small cell lung cancer (NSCLC) designed to evaluate first line treatment with gemcitabine vs. erlotinib vs. the combination of gemcitabine and erlotinib. Single agent therapy is considered standard of care in elderly patients with advanced stage NSCLC. Several agents, including vinorelbine, gemcitabine, and docetaxel have been examined in the elderly population. Erlotinib has also recently been shown to improve overall survival in NSCLC patients with refractory disease. Erlotinib is currently being evaluated as first-line monotherapy in previously untreated elderly patients with advanced NSCLC and early data suggest this agent is both active and well tolerated in this disease setting. Recently, the addition of erlotinib to gemcitabine in patients with advanced pancreatic cancer was shown to improve overall survival and progression free survival compared to gemcitabine alone. This trial represents an effort to better understand both the activity of single agent erlotinib as well as the potential combined benefit of gemcitabine and erlotinib in elderly patients with advanced stage NSCLC.

Despite our efforts to improve outcomes in elderly patients with advanced stage NSCLC, the prognosis is still poor. The median survival with single agent gemcitabine in the MILES trial was 7 months and response rate was only 16%. Ongoing investigation of treatment with erlotinib alone is encouraging as evidenced by the Phase II trial conducted by researchers at the Dana Farber Cancer Institute. Median survival in this trial was 11 months and response rate was 12%. Improved efficacy with the combination of agents is suggested by the NCI of Canada trial, which demonstrated improvement in both overall survival and progression free survival. Incorporation of newly developed targeted therapies, particularly the EGFR tyrosine kinase inhibitors, into ongoing clinical trials is imperative, especially in a population of patients that is frequently underrepresented.

Minimum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

1. Histologic or cytologic diagnosis of stage NSCLC

2. Age ≥ 70 years

3. ECOG PS 0-2

4. Adequate end-organ function defined as follows:

ANC ≥ 1. 5 Platelets ≥ 100,000 Hemoglobin ≥ 8. 0 g/dl AST/ALT ≤ 2. 5 upper limit of institutional normal Alkaline phosphatase ≤ 4 x ULN Total Bilirubin below or equal to upper institutional normal limits Serum Creatinine ≤ 1. 5 x ULN

5. Patients may have received 1 prior treatment in the adjuvant setting, but time since prior chemotherapy must be ≥1 year. Although the protocol specifically says adjuvant therapy, we believe neo-adjuvant is similar and patients who have received neo-adjuvant (pre-operative) rather than classic adjuvant (post-operative) therapy are similar and should not be distinguished. Therefore, patients may have received 1 prior treatment in the neo-adjuvant setting as well.

6. Treated brain metastases are eligible provided the patient is asymptomatic and meets the above criteria, including PS.

7. Measurable disease by RECIST criteria

8. Ability to give informed consent

Exclusion Criteria:

1. Patients with a history of severe hypersensitivity to gemcitabine.

2. Incompletely healed from previous oncologic or other major surgery.

3. Pregnancy or breast feeding (women of childbearing potential are not expected to be enrolled in this study given section 4. 1.2)

4. Patients with severe co-morbid illness.

5. Patients unable to participate in the QOL assessments.

Maureen Tynan, RN, OCN, Phone: 919-966-4432, Email: tynanm@med.unc.edu

Highlands Oncology Group, Springdale, Arkansas 72764, United States; Recruiting
Wendy Parnell, Phone: 479-872-8130, Email: wparnell@hogonc.com
Patricia Duncan, Phone: 479-872-8130, Email: onc14@hogonc.com
Daniel Bradford, MD, Principal Investigator

Summit Cancer Care, Savannah, Georgia 31405, United States; Recruiting
Lynn Davis, RN, Phone: 912-651-5714, Email: ldavis@summitcancercare.com
Mark Taylor, MD, Principal Investigator

Hackensack University Medical Center, Hackensack, New Jersey 07601, United States; Recruiting
Diane Denbleyker, RN, Phone: 201-336-8066, Email: ddenBleyker@humed.com
Harry Harper, MD, Principal Investigator

University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina 27599, United States; Recruiting
Maureen Tynan, RN, Phone: 919-966-4432, Email: tynanm@med.unc.edu
Tammy Allred, RN, Phone: 919-966-4432, Email: Tammy_Allred@med.unc.edu
Mark A Socinski, MD, Principal Investigator

Rex Healthcare/Rex Cancer Center, Raleigh, North Carolina 27607, United States; Recruiting
Nancy Burns, RN, BSN, OCN, Phone: 919-784-7209, Email: nancy.burns@rexhealth.com
Jeffrey Crane, MD, Principal Investigator

Northeast Medical Center - Northeast Oncology Associates, Concord, North Carolina 28025, United States; Recruiting
Sheri Brosnahan, RN, Phone: 704-783-1520, Email: sbrosnahan@northeastmedical.org
Garry Schwartz, MD, Principal Investigator

Cape Fear Valley Health System - Carolina Cancer Management, Fayetteville, North Carolina 28304, United States; Recruiting
Mary H Kulig, RN, Phone: 910-609-6931, Email: mkulig@capefearvalley.com
Kamal Bakri, MD, Principal Investigator

Wellmont Holston Valley Medical Center - Kingsport Hem/Onc, Kingsport, Tennessee 37660, United States; Recruiting
Teresa Bailey, RN, BSN, OCN, Phone: 423-224-3738, Email: Teresa_W_Bailey@Wellmont.org
Edwin McElroy, MD, Principal Investigator

University of Tennessee - VA Medical Center at Memphis, Memphis, Tennessee 38104, United States; Recruiting
Julie Madison, RN, BSN, Phone: 901-523-8990, Email: Julie.Madison@va.gov
Harvey Niell, MD, Principal Investigator

UNC Lineberger Comprehensive Cancer Center clinical trials page

Starting date: March 2006
Last updated: May 23, 2007