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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 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:
Jane Taylor, RSC 256-327-5646
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
Novartis CASA4042302
A Phase III, randomized, double-blind, placebo-controlled study of ASA404 in combination with Docetaxel in second line treatment of patients with Advanced or Metastatic (StageIIIb/IV) Non-Small Cell Lung Cancer
Rationale:
ASA404 is a novel tumor vascular disrupting agent that has shown strong synergistic activity with the taxane, i.e docetaxel. ASA404 has the potential to further improve the treatment options of patients in the second line setting of NSCLC.
Purpose:
The purpose of this study is to determine if adding ASA404 to Docetaxel makes Docetaxel more effective in advanced lung cancer
Eligibility:
- Must have histologically confirmed stage IIIb or IV NSCLC
- Must have had progression while on or following a first-line chemotherapy regime for stage IIIb or IV NSCLC
- No prior treatment with docetaxel for NSCLC in the first-line setting
- Must not have CNS metastases
- No significant heart disease, implanted cardiac pacemaker or history of myocardial infarction within 12 months
- Must not have severe peripheral neuropathy
Treatment:
1 to 1 Randomization
- ARM A: Docetaxel 75mg/m2 IV over one hour, and then ASA404 1800mg/m2 IV over 20 minutes every 3 weeks for 6 cycles
- ARM B: Docetaxel 75mg/m2 IV over one hour, and then placebo IV over 20 minutes Every 3 weeks for 6 cycles
Contact:
Avitra Bone RN, BSN (256)705-4283
Current Clinical Trials:
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