Clearview Cancer Center

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Clinical Trials

Did you know Clearview Cancer Institute has been involved in Clinical Research for over 18 years? Findings from clinical trial research have led to significant advances in cancer prevention and treatment, and Clearview offers numerous clinical trials whereby patients who volunteer for them receive innovative, state-of-the-art cancer care.

Lung Cancer

A Phase 1/2 Maximum Tolerated Dose Study of Belinostat (PXD-101) in Combination with Paclitaxel plus Carboplatin in Chemotherapy-naive Patients with Stage IV Non-Small-Cell Lung Carcinoma (NSCLC)

Rationale:

Non-small-cell lung carcinoma (NSCLC) is a leading cause of cancer death world wide. The current standard of care for front-line treatment of patients with advanced NSCLC consist of systemic chemotherapy that is chosen based in part of the type of cancer cell and other symptoms that you are experiencing. Belinostat (the study drug) is an inhibitor of an enzyme (HDAC - important to tumor growth) and increases the anti-tumor activity of the standard of care drugs: Paclitaxel and Carboplatin.

Purpose:

To determine the maximum tolerated dose (MTD) of Belinostat in combination with Carboplatin and Paclitaxel in patients with stage IV NSCLC who have received no prior systemic chemotherapy

Eligibility:

Diagnosis of Stage IV NSCLC.

No systemic chemotherapy for advanced NSCLC. Prior adjuvant treatment for early stage lung cancer is allowed, provided it has been at least 12 months.

Patients must have adequate lab values to participate.

Patients that have HIV, Hep B or C are excluded.

Patients on certain medications or with Long QT syndrome are excluded.

Treatment:

Patients will receive Belinostat on days 1-5, and on day three (3) will receive Paclitaxel and Carboplatin every 21 days for six (6) cycles

Contact:

Leslie Smoot, RN; 256-705-4246




A Randomized Phase II study of Imetelstat as Maintenance Therapy after Initiation Induction Chemotherapy for Advanced NSCLC

Rationale:

• The median one year survival rates for NSCLC patients treated with a platinum-based doublet therapy is approximately 8 months • Telomerase – is a necessary enzyme for tumor growth following chemotherapy; imetelstat inhibits telomerase. This study is designed to test the effects of imetelstat on preventing tumor growth following chemotherapy.

Purpose:

• Progression Free Survival (PFS) • Assess the safety and tolerability of Imetelstat as part of maintenance chemotherapy in patients with Advanced NSCLC

Eligibility:

• Stage IIIb, Stage IV or recurrent locally advanced disease not amendable to radiation or surgery with curative intent • Patients must have completed 4 cycles (no more than 4) of platinum based chemotherapy doublet for first line, Advanced NSCLC, with no evidence of disease progression per RECIST. • Induction therapy within 21 days but no more than 42 days • No Alimta or Tarceva • Adjuvant chemotherapy greater than 1 year prior to progression • Ecog 0-1 • Willingness to continue treatment with Bevacizumab

Treatment:

• 2:1 Randomization • Imetelstat 9.4mg/kg IV d 1, 8 + Standard therapy (Bev 15mg/kg d1or observation) • Standard therapy (Bev 15mg/kg d 1 or observation)

Contact:

Avitra Bone; RN, BSN (256) 705-4283




Randomized Phase 3 Trial of Gemcitabine/Carboplatin with or without BSI-201 (a PARP1 Inhibitor) in Patients with Untreated Stage IV Squamous Non-Small-Cell Lung Cancer

Rationale:

BSI-201 is a highly lipophilic PARP1 inhibitor that distributes rapidly and widely into tissues, including the brain and cerebrospinal fluid. BSI-201 was designed to stop cancer cells from repairing themselves after they have been damaged by chemotherapy. Both BSI-201 and its metabolites have shown to elicit anti-neoplastic effects through inhibition of PARP.

Purpose:

The primary objective of this study is to compare the overall survival of patients treated with gemcitabine/carboplatin plus BSI-201 vs. gemcitabine/carboplatin alone.

Eligibility:

Key Inclusion: • Newly diagnosed, stage IV SCLC. This includes patients who present with disseminated mets, and those with a malignant pleural or pericardial effusion • Presence of measurable or non-measurable disease. • ECOG 0 or 1 Key Exclusion: • Active brain metastases. Patients with treated brain mets are eligible, if radiation therapy was completed at least 2 weeks prior to study entry; follow up scans show no disease progression and patient doesn’t require steroids • A major surgical procedure, open biopsy, or significant injury less or equal to 28 days of beginning treatment, or anticipation of the need for major surgery during the course of the study. • A history of cardiac disease defined by: malignant HTN, unstable angina, CHF, MI within the previous 6 months, symptomatic cardiac arrhythmias

Treatment:

ARM A: Gemcitabine/carboplatin + BSI-201 Gemcitabine: 1000mg/m2; IV; on Day 1 and Day8 of each 21 day cycle Carboplatin: AUC+5; IV; on Day 1 of each 21 day cycle BSI-201: 5.6mg/kg; IV; on Days 1, 4, 8 and 11 of each 21 day cycle ARM B: Gemcitabine/Carboplatin Gemcitabine: 1000mg/m2; IV; on Day 1 and Day 8 of each 21 day cycle Carboplatin: AUC= 5: IV; on Day 1 of each 21-day cycle

Contact:

Avitra Bone; RN, BSN (256) 705-4283




Current Clinical Trials:

[Emily Pauli, Pharm.D.]Emily Pauli, Pharm.D.Director of Research

If you are interested in more information on clinical trials at Clearview, please feel free to contact us (256) 705-4224. More information regarding clinical trials can be found at: www.ClinicalTrials.gov

Entering a Clinical Trial: Is it right for you? Download the PDF.