Lakeland Regional Medical Center

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Lakeland Regional Cancer Center
Lakeland Regional Cancer Center

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Lakeland Regional Cancer Center

Lakeland Regional Cancer Center

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Lung Cancer

  1. A Randomized, Double-Blind, Placebo-Controlled Multicenter Phase 2 Study of the Efficacy and Safety of Apricoxib in Combination with Erlotinib in Non-Small Cell Lung Cancer Patients
  2. Phase 2 Randomized Study of Ezatiostat Hydrochloride (Twelintra, TLK199 Tablets) For Treatment of Chemotherapy Induced Neutropenia in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer Receiving First-Line Chemotherapy
  3. A Randomized Phase II Study Evaluating Vandetanib (ZD6474) in Combination with Docetaxel and Carboplatin Placebo or Maintenance Therapy with Vandetanib in Patients with IIIB, IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)
  4. A Phase III, Randomized, Double-Blind, Placcebo-Controlled Multi-Center Study of ASA404 in Combination with Docetaxel in Second-Line Treatment of Patients with Advanced or Metastatic (Stage IIIb/IV) Non-Small Cell Lung Cancer
  5. Randomized, Open-Label, Phase III Trial of CP-751,871 in COmbination with Paclitaxel and Carboplatin Versus Paclitaxel and Carboplatin in Patients with Non-Small Cell Lung Cancer
  6. A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB (>/= 4cm) -IIIA Non-Small Cell Lung Cancer (NSCLC)
  7. A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With COmpletely Resected STage IB (>/= 4cm) – IIIA Non-Small Cell Lung Cancer (NSCLC)

A Randomized, Double-Blind, Placebo-Controlled Multicenter Phase 2 Study of the Efficacy and Safety of Apricoxib in Combination with Erlotinib in Non-Small Cell Lung Cancer Patients

Eligibility Criteria (per Protocol dated 06/22/2009):

  1. Pathologically determined stage IV non-small cell lung cancer, including stage IIIb (pleural effusion) (histology or cytology acceptable).
  2. Subject has failed at least one prior platinum-based chemotherapy for stage IIIb or stage IV non-small cell lung cancer.
  3. Subject must have measurable disease by Response Evaluation Criteria in Solid Tumors at least 20mm for conventional CT scan or at least 10mm for spiral CT scan.
  4. ECOG Performance Status of 0 or 1.
  5. Not eligible if there was radiation therapy within 2 weeks, or chemotherapy within 3 weeks or non-cytotoxic investigational agents within 4 weeks of initiating study treatment. Subjects must have recovered from adverse effects (except hair loss and NCI Common Toxicity Criteria grade 1 neuropathy) due to agents administered prior to initiating study treatment.
  6. Not eligible if there is evidence of New York Heart Association class III or greater heart disease.
  7. Not eligible if there is history of myocardial infarction (heart attack), stroke, ventricular arrhythmia, or symptomatic conduction abnormality within 12 months.
  8. Not eligible if there is a known human immunodeficiency virus infection or acquired immune deficiency syndrome (testing is not required).
  9. Not eligible if there is hypersensitivity or intolerance to apricoxib, erlotinib, sulfonamides, aspirin, or other non-steroidal anti-inflammatory drugs (NSAIDs).
  10. Other criteria, as determined by the protocol.

For information about this study, please contact Robin Stewart, RN, PhD, CCRC at (863) 904-1877.

Phase 2 Randomized Study of Ezatiostat Hydrochloride (Twelintra, TLK199 Tablets) For Treatment of Chemotherapy Induced Neutropenia in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer Receiving First-Line Chemotherapy

Inclusion Criteria (Per protocol dated 10/01/08):

  1. Histologically confirmed NSCLC, including squamous cell carcinoma, undifferentiated carcinoma, adenocarcinoma, mixed (adnocarcinoma with squanous cell carcinoma; mixed tumors will be categorized by the predominant cell type, those containing small cell lung carcinoma elements are not eligible), bronchoalveolar carcinoma, or large cell carcinoma.
  2. Stage IIIB (with pleural effusion not eligible for surgery, or combined modality chemoradiation) or Stage IV disease not curable with surgery, radiation or combined modality therapy at randomization or recurrent or resistant disease if completion of neoadjuvant or adjuvant treatment was greater than one year from randomization.
  3. ECOG Performance status of 0-2.
  4. Adequate liver and renal function.
  5. Adequate bone marrow reserve.
  6. Not eligible if there has been treatment with a neoadjuvant or adjuvant chemotherapy regimen within 1 year.
  7. Not eligible if there is hitologically confirmed mixed tumors containing small cell lung carcinoma elements.
  8. Not eligible if there history of bone marrow transplantation or stem cell support.
  9. Not eligible if there is leptomeningeal metastases or carcinomatous meningitis.
  10. Other criteria, as determined by the protocol.

For more information about this study, please contact Robin Stewart, RN, PhD, CCRC at (863) 904-1877.

A Randomized Phase II Study Evaluating Vandetanib (ZD6474) in Combination with Docetaxel and Carboplatin Placebo or Maintenance Therapy with Vandetanib in Patients with IIIB, IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)

Eligibility Criteria (per Protocol dated 07/23/08):

  1. Histologically or cytologically confirmed non-small cell lung cancer (NSCLC).
  2. Must have advanced stage or recurrent NSCLC.
  3. ECOG performance status of 0 or 1.
  4. Subject must have measurable disease according to the RECIST criteria.
  5. Subjects with basal cell or squamous cell carcinoma of the skin or in situ of the cervix within the past 5 years must have been treated with curative intent and have been free of disease for more than 3 years.
  6. No prior therapy for metastatic disease.
  7. No major surgical procedures within 4 weeks of study entry, or have an incompletely healed surgical incision.
  8. Prior radiation is allowed if completed at least 2 weeks prior to therapy and provided the subject recovers from the side effects.
  9. Subject may have had prior brain metastases if they completed treatment at least 4 weeks (2 weeks stereotactic radiotherapy) and are clinically stable without steroid therapy for one week prior to randomization.
  10. Other criteria, as determined by the protocol.

For information about this study, please contact Robin Stewart, RN, PhD, CCRC at (863) 904-1877.

A Phase III, Randomized, Double-Blind, Placcebo-Controlled Multi-Center Study of ASA404 in Combination with Docetaxel in Second-Line Treatment of Patients with Advanced or Metastatic (Stage IIIb/IV) Non-Small Cell Lung Cancer

Eligibility Criteria (per Protocol dated 07/22/08):

  1. Histologically confirmed non-small cell carcinoma of the lung of all histologies (histological or cytological specimens must be collected via surgical biopsy, bruishing, washing, core needle aspiration of a defined lesion. Sputum cytology is not acceptable.
  2. Subjects who have progressed while on or following a first-line chemotherapy regimen for Stage IIIb disease (malignant pleural effusion or pericardial effusion that have been confirmed cytologically) or Stage IV disease. Subjects who have received bevacizumab and/or EGFR inhibitors in first-line will be eligible.
  3. WHO performance status of 0-2.
  4. Laboratory values within the study range, and within 2 weeks of randomization.
  5. Subject not eligible if there is CNS metastases.
  6. Subject not eligible if there is a history of another primary malignancy within 5 years of randomization with the exception of non-melanoma skin cancer, or cervical cancer in situ.
  7. Subject not eligible if there has been radiotherapy within 2 weeks prior to randomization. Subject must have recovered from all radiotherapy-related toxicities.
  8. Subject not eligible if there has been major surgery within 4 weeks prior to randomization (major surgery is defined by the use of genereal anesthesia). Endoscopic examinations with diagnostic intent are not considered major surgery. Minor surgery must have been within 2 weeks prior to randomization. Insertion of a vascular access device is not considered major or mino surgery. Subject must have recovered from all surgery-related complications.
  9. Subject not eligible if there has been treatment with first-line chemotherapy within 3 weeks prior to randomization (or within 6 weeks if treatment with bevacizumab, mitomycin and nitrosoureas has been given).
  10. Other criteria, as determined by the protocol.

For information about this study, please contact Robin Stewart, RN, PhD, CCRC at (863) 904-1877.

Randomized, Open-Label, Phase III Trial of CP-751,871 in COmbination with Paclitaxel and Carboplatin Versus Paclitaxel and Carboplatin in Patients with Non-Small Cell Lung Cancer

Eligibility Criteria (per Protocol dated 11/21/07):

  1. Histologically or cytologically confirmed diagnosis of non-small cell lung cancer with a primary histology of predominantly squamous cell, large cell or adenosquamous carcinoma (refer to protocol). No histological/cytological evidence of small cell or carcinoid lung cancer is permitted. Subjects with a primary histology of adenocarcinoma NSCLC and those with unknown or unspecified (not otherwise specified) NSCLC histology will be excluded.
  2. Advanced NSCLC with documented Stage IIIB (with pleural effusion) or Stage IV or recurrent disease.
  3. No prior systemic treatment for NSCLC, except for adjuvant chemotherapy. Adjuvant chemotherapy must have been completed at least 12 months prior to randomization.
  4. Prior surgery or radiation therapy is permitted if completed at least 3 weeks prior to randomization and all acute toxicities have resolved to CTC Grade 1.
  5. ECOG Performance status of 0 or 1.
  6. Adequate organ function as determined by protocol criteria.
  7. SUbjects with symtpomatic central nervous system (CNS) metastases are not eligible.
  8. No other active malignancies (other than non-adenocarcinoma NSCLC).
  9. Enrollment in another therapeutic clinical trial is not permitted.
  10. Other criteria, as determined by the protocol.

For information about this study, please contact Robin Stewart, RN, PhD, CCRC at (863) 904-1877.

A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB (>/= 4cm) -IIIA Non-Small Cell Lung Cancer (NSCLC)

Eligibility Criteria (per protocol dated 05/2009- Addendum 7):

  1. ECOG Performance status of 0 or 1.
  2. Subject must not have received prior systemic chemotherapy, hormonal cancer therapy or radiation therapy as prior cancer treatment within 5 years of randomization (prior surgery, biologic therapy, hormonal therapy, or radiation therapy for a malignancy over 5 years prior to enrollment that is now considered cured is acceptable).
  3. SUbject must not have had any history of cancer within 5 years from randomization, with the exception of in-situ carcinoma of the cervix or completely resected non-melanoma skin cancer.
  4. No history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days prior to randomization.
  5. No anticipated major surgical procedure(s) during the course of the study.
  6. No hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies.
  7. no serious non-healing wounds, ulcers, bone fractures, or major surgical procedures, open biosy, or significant traumatic injru within 28 days prior to randomization OR core biopsy within 7 days prior to randomization.
  8. No history of bleeding diathesis or coagulopathy.
  9. No anticipated major surgical procedure(s) over the course of the study.
  10. Other criteria, as determined by the protocol.

For more information, contact Robin S. Stewart, RN, PhD, OCN, CCRC, at (863) 904-1900.

A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With COmpletely Resected STage IB (>/= 4cm) – IIIA Non-Small Cell Lung Cancer (NSCLC)

Eligibility Criteria (per protocol dated 05/2009- Addendum 7):

  1. ECOG Performance status of 0 or 1.
  2. Subject must not have received prior systemic chemotherapy, hormonal cancer therapy or radiation therapy as prior cancer treatment within 5 years of randomization (prior surgery, biologic therapy, hormonal therapy, or radiation therapy for a malignancy over 5 years prior to enrollment that is now considered cured is acceptable).
  3. SUbject must not have had any history of cancer within 5 years from randomization, with the exception of in-situ carcinoma of the cervix or completely resected non-melanoma skin cancer.
  4. No history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days prior to randomization.
  5. No anticipated major surgical procedure(s) during the course of the study.
  6. No hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies.
  7. no serious non-healing wounds, ulcers, bone fractures, or major surgical procedures, open biosy, or significant traumatic injru within 28 days prior to randomization OR core biopsy within 7 days prior to randomization.
  8. No history of bleeding diathesis or coagulopathy.
  9. No anticipated major surgical procedure(s) over the course of the study.
  10. Other criteria, as determined by the protocol.

For more information, contact Robin S. Stewart, RN, PhD, OCN, CCRC, at (863) 904-1900.

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