| Thoracic
Trials
|
| TITLE |
GENE 1505: A Phase III,
Multicenter, Placebo-Controlled, Double Blind, Randomized Clinical Trial to Evaluate the Efficacy of Bevacizumab in Combination with Tarceva™
(Erlotinib) Compared with Tarceva Alone for Treatment of Advanced Non-Small Cell Lung Cancer
(NSCLC) After Failure of Standard First-Line Chemotherapy. |
| DESCRIPTION |
This study will evaluate the efficacy of combining bevacizumab with Tarceva
(erlotinib) relative to Tarceva monotherapy in second-line patients with advanced
NSCLC, as measured by overall survival. Patients will be randomized to one of two treatment arms: Arm 1: Tarceva + placebo; Arm 2: Tarceva +
bevacizumab.
|
| ELIGIBILITY
|
- Age ≥ 18 years
- Cytologically or histologically confirmed NSCLC and must have archival diagnostic tissue available for analysis
- Clinical or radiographic progression during or after first-line chemotherapy treatment for Stage IIIB/IV disease
- Must not have had prior therapy with an investigational or marketed inhibitor of the EGFR pathway or anti-angiogenesis agent
- No history of gross hemoptysis in the prior 3 months.
- ECOG performance status of 0, 1, or 2
|
| CONTACT |
Kim Rutherford RN 216-844-8988 |
| TITLE |
WAGM 1505: A Phase II Study of HKI-272 in Subjects with Advanced Non-Small Cell Lung Cancer |
| DESCRIPTION |
The purpose of this study is to determine whether HKI-272 is safe and is useful in treating non-small cell lung cancer. Patients will be receive HKI-272 given in daily oral doses of 320 mg. In addition, a sample of the tumor will be obtained for DNA analysis. |
| ELIGIBILITY
|
- Age ≥ 18 years
- Pathologic diagnosis of NSCLC and current stage IIIB (with pleural effusion) or IV, not curable with conventional therapy. A sample of tumor must be available.
- Must have progressive disease following at least 12 weeks of therapy with Tarceva or Iressa
- No active brain metastases
- No more than 2 prior chemotherapy regimens for relapsed or metastatic disease. No prior therapy with EGFR/HER-2 targeted therapy
- ECOG performance status 0 – 2
- Patients must have normal bone marrow, liver, heart and kidney function.
|
| CONTACT |
Kim Rutherford RN 216-844-8988 |
| TITLE |
MLNM 2505:
A Randomized, Non-comparative, Multicenter, Open-Label, Phase II Study of Tarceva™
(erlotinib) Alone and of Tarceva plus Velcade (bortezomib) for Injection in Patients with Relapsed or Refractory, Locally Advanced or Metastatic Non-Small Cell Lung Cancer |
| DESCRIPTION |
This study will evaluate how tumors respond to treatment with Tarceva alone or Tarceva in combination with VELCADE and will try to establish how the combination of Tarceva and VELCADE are tolerated and how these drugs affect the quality of life of patients. VELCADE will be administered on day 1 and day 8 of each 3-week cycle. |
| ELIGIBILITY
|
- Age > 18 years.
- Stage IIIB or Stage IV NSCLC that has been histologically or cytologically confirmed with documented disease progression
- One prior line of conventional cytotoxic chemotherapy for Stage IIIB or Stage IV disease not to include any anti-epidermal growth factor receptor
(EGFR) antibody or anti-EGFR tyrosine kinase inhibitor
- Normal bone marrow, kidney and liver function
- Must have ECOG performance status 0 or 1
- Life expectancy of > 3 months
|
| CONTACT |
Kim Rutherford RN 216-844-8988 |
| TITLE |
MLNM
1505: A Multicenter, Open Label, Phase II Study of VELCADE (bortezomib) for Injection in Previously Treated Patients with Stage IIIB and IV Bronchioalveolar Carcinoma and Adenocarcinoma with Bronchioalveolar Features |
| DESCRIPTION |
This study will determine how tumors in patients with a type of non-small cell lung cancer known as bronchioloalveolar carcinoma (also called BAC) respond to treatment with the drug VELCADE®
(bortezomib). The study will also evaluate the effects of the drug on the patient, and quality of life issues such as number of visits to the doctor or to the hospital necessary after treatment. Portions of the tumor will also be tested for specific changes in genes known to be involved in lung cancer and response to treatment (but not for inherited characteristics). VELCADE® will be injected (a needle under the skin) on four separate days in each 21-day time period (a cycle), over the course of about 3-6 months. This time could be extended if there is a positive response to treatment.
|
| ELIGIBILITY
|
- Must have histologically confirmed BAC or adenocarcinoma with BAC features and stage IIIB (malignant pleural effusion) or stage IV disease
- Must have disease that has progressed on or after treatment with an EGFR tyrosine kinase inhibitor (Iressa or
Tarceva)
- Must have radiographic documentation of progressive disease and measurable disease by RECIST
- Must be 18 years of age or older
- Must have life expectancy greater than 3 months
- Must have ECOG performance status of 0, 1, or 2
|
| CONTACT |
Kim Rutherford, RN 216-844-8988 |
| TITLE |
E 2501: A Double blind Phase II Study of BAY 43-9006 in Patients with Nonsmall Cell Lung Cancer Who Have Failed at Least Two prior Chemotherapy Regimens |
| DESCRIPTION |
This research study is
being conducted in patients with advanced lung cancer that cannot be
treated with surgery or radiation therapy, and which no longer responds to
chemotherapy. The purpose of this study is to find out if BAY 43-9006 (the
study drug) will slow the growth of the cancer in patients who receive
extended treatment with BAY 43-9006 compared to those who do not continue
on the treatment right away but have a “break” until their cancer
starts to grow.
After two months of treatment on the study, the cancer will be evaluated.
If the cancer is worse, participation in the study will end and other
treatment options will be discussed. If the cancer is the same,
participation will continue and the patient will be randomized (put into a
treatment group by chance, like the flip of a coin) to continue receiving
more therapy with either BAY 43-9006 or a placebo.
|
| ELIGIBILITY |
- Have documented advanced non-small cell lung cancer;
- Have had at least two prior chemotherapy regimens for non-small cell lung cancer and must have progressing disease;
- Be 18 years of age or older;
- Have good organ function;
- Not have clinically evident congestive heart failure, serious arrhythmias, or symptoms of coronary heart disease;
- Not have an active secondary malignancy or a clinically serious active infection;
|
| CONTACT |
Kim Rutherford, RN 216-844-8988 |
| TITLE |
HANA 1504 A Phase I/II, Open- Label, Multicenter Study of Single Agent PT-523 in the
Treatment of Relapsed or Refractory Non-Small Cell Lung Cancer (NSCLC) |
| DESCRIPTION |
This study is being done to evaluate the safety of the single agent drug, PT-523, (in
Phase I), and the safety and tolerability of the drug (in Phase II) in patients with
relapsed or refractory non-small cell lung cancer (NSCLC). In Phase I of the study
patients will receive the single agent drug, PT-523, administered intramuscularly
(IV) as a 5 minute infusion on days 1, and 8, of a 21 day cycle. Patients will be
followed for 30 days after their last dose. Patients with evidence of stable or
responding diseased will receive subsequent therapy of PT-523 in the Phase II portion
of the study. Patients in Phase II of the study will be evaluated for response,
survival, time to progression of the disease and toxicity. |
| ELIGIBILITY
|
- Patients must have a confirmed diagnosis of Stage III or IV non-small cell
lung cancer, or recurrent disease and failed first and second-line chemotherapy
regimens.
- Patients may not have received the study agent, PT-523, prior to entry into
the study.
- Patients must be asymptomatic or treated brain metastases if last therapy was
received before fours week entry into the study.
- At least four week must have elapsed from the time of major surgery, and
patients must have recovered from any effects of any significant procedures.
- There must be a 3 week interval from the last does of chemotherapy prior to
beginning the protocol therapy. Palliative radiotherapy to bony sites of disease is
permissible.
- Patients must have an ECOG performance stays of 0-2.
- Patients must have normal organ and bone marrow function within 14 days of
entry into the study
|
| CONTACT |
Kim Rutherford, RN 216-844-8988 |
| TITLE |
E 6501: Interferon Alpha
(NSC#377523) Plus 13-Cis-Retinoic Acid Modulation of BCL-2 Plus Paclitaxel for Recurrent Small Cell Lung Cancer (SCLC) |
| DESCRIPTION |
This study is being done to evaluate the response frequency of interferon-alpha, cis-retinoic acid (as a means of modulation of bcl-2) and paclitaxel to enhance drug response. Patients will receive Interferon alpha and 13-cis-retinoic acid on days 1 and 2 each week for 6 weeks then 2 weeks of rest during an 8 week cycle. Patients will be assessed for disease response after the first 8-week cycle. Patients with complete or partial response, or stable disease may be considered for further therapy. Those with progressive disease will discontinue protocol treatment. |
| ELIGIBILITY
|
- Patients must have histologically or cytologically confirmed recurrent SCLC with clinically confirmed measurable disease. X-rays or scans used to document measurable disease must be obtained within 4 weeks prior to registration.
- Patients must have had prior chemotherapy treatment for SCLC.
- Patients must not have had radiation therapy or chemotherapy within 60 days of registration.
- Patients must not have had any prior paclitaxel or interferon alpha therapy.
- Patients must have normal kidney, liver and bone marrow function.
|
| CONTACT |
Ann
Ness, RN 216-844-1637 |
| TITLE |
CASE 1503: Phase II Trial of XL119
(Rebeccamycin Analogue) in Relapsed Sensitive Small Cell Lung Cancer |
| DESCRIPTION |
This study will evaluate the objective response rate of XL119 in limited or extensive stage SCLC patients. Patients will receive XL119 once a day for 5 days every 3 weeks for 6-cycles or until disease progression.
|
| ELIGIBILITY
|
- Patients must have sensitive (progression greater than or equal to 90 days after completing first-line therapy) relapsed small cell lung cancer.
- Patients may have received prior chemotherapy or radiation therapy.
- Patients must have a life expectancy of at least 12 weeks.
- Patients with brain metastasis are eligible if they have stable brain disease and are no longer receiving irradiation and do not require steroids to control symptoms.
- Patients must have normal bone marrow, liver and kidney function.
|
| CONTACT |
Ann
Ness, RN 216-844-1637 |
| TITLE |
VICC 1503: Phase II Study of Concurrent Chemoradiotherapy with Weekly
Docetaxel, Carboplatin and Radiation Therapy Followed by Consolidation Chemotherapy with Docetaxel and Carboplatin for Locally Advanced Inoperable Non-Small Cell Lung Cancer |
| DESCRIPTION |
This study will determine the overall response rate for advanced NSCLC patients receiving concurrent chemoradiotherapy with weekly
docetaxel, carboplatin and radiation therapy followed by two cycles of consolidation chemotherapy with docetaxel and
carboplatin. Patients will receive docetaxel, carboplatin and radiation therapy once a week for 7 weeks followed by consolidation docetaxel and carboplatin once a week for 3 weeks for a total of 2 cycles. |
| ELIGIBILITY
|
- Patients must have
non-metastatic, inoperable, Stage IIIA or IIIB histologically or cytologically documented NSCLC without evidence of malignant pleural effusion.
- Patients must not have received any prior systemic chemotherapy, thoracic radiotherapy or surgical resection for treatment of
NSCLC.
- Patients must have at least one site of unidirectionally measurable disease.
- Patients must be more than 3 weeks from a formal exploratory
thoracotomy.
- Patients must have normal bone marrow, kidney and liver function.
|
| CONTACT |
Ann
Ness, RN 216-844-1637 |
| TITLE |
S0220: A Phase II Trial of Induction Chemoradiotherapy with
Cisplatin/Etoposide Followed by Surgical Resection, Followed by
Docetaxel, for Non-Small Cell Lung Cancer Involving the Superior Sulcus
(Pancoast Tumors) |
| DESCRIPTION |
This study will assess overall survival in patients with Pancoast tumors without mediastinal or supraclavicular nodal involvement. Patients will be treated with cisplatin and etoposide for two cycles, concurrent with continuous, fractionated chest radiation followed by surgical resection and consolidation chemotherapy with
docetaxel. |
| ELIGIBILITY
|
- Patients must have selected Stage
IIB, IIIA or IIIB non-small cell lung cancer due to involvement of the superior
sulcus.
- Patients must have either histologic or cytologic proof of a newly diagnosed single primary bronchogenic non-small cell lung cancer.
- Patients with either pericardial effusions or superior vena cava syndrome are not eligible.
- Patients must not have any evidence of distant metastatic disease.
- Patients must have normal bone marrow, kidney and liver function.
|
| CONTACT |
Ann
Ness, RN 216-844-1637 |
| TITLE |
LILY 2503: Randomized Phase II Trial of
Cisplatin, Etoposide and Radiation Followed by Gemcitabine versus Gemcitabine and Docetaxel in Stage IIIB Unresectable Non-Small Cell Lung Cancer |
| DESCRIPTION |
This study will assess two-year survival in patients with stage IIIB unresectable non-small cell lung cancer
(NSCLC) receiving consolidation gemcitabine or gemcitabine and docetaxel following concurrent chemotherapy/radiotherapy. All patients will receive two cycles of induction chemotherapy consisting of Cisplatin and Etoposide plus induction radiation therapy followed by boost radiation therapy. Patients will be restaged at week 10 and patients with no evidence of local progression or distant metastases will be randomized to receive either 3 cycles of gemcitabine alone or 3 cycles of gemcitabine plus
docetaxel. |
| ELIGIBILITY
|
- Patients must have either histologic or cytologic evidence of a single, primary bronchogenic non-small cell lung cancer.
- Patients with two or more distinct parenchymal lesions on same or opposite sides of the lung are not eligible.
- Patients must have Stage IIIB disease.
- Patients must not have received any prior chemotherapy or radiotherapy for lung cancer.
- Patients must have normal bone marrow, liver, kidney, cardiac and lung function.
- Patients must be at least 18 years of age.
|
| CONTACT |
Ann
Ness, RN 216-844-1637 |
| TITLE |
PFIZ 1Y03: A
Multicenter, Open Label, Noncomparative Phase I-II Clinical and Pharmacokinetic Study of Oral PD0325901 in Patients with Advanced Cancer |
| DESCRIPTION |
This study will determine the safety profile including dose-limiting toxicities of oral PD0325901. Patients will receive oral PD0325901 once daily for 21 consecutive days followed by a 1-week holiday. Treatment cycles will repeat every 28 days. |
| ELIGIBILITY
|
1. Patients must be at least 18 years of age.
2. Patients must have tumor accessible for biopsy and willingness to undergo baseline and post-treatment biopsy.
3. Patients must have biopsiable breast cancer, colorectal cancer, NSCLC or melanoma proven histologically or cytologically at original diagnosis, refractory to treatment, or for which no standard treatments exist.
4. Patients must have adequate bone marrow, liver and kidney function.
5. Patients must not be receiving ongoing radiation therapy, or prior radio-,
cytotoxic, immunotherapy, biologic therapy, or molecular targeted therapies within 4 weeks prior to registration or hormonal therapy within 2 weeks prior to registration. |
| CONTACT |
Ann
Ness, RN 216-844-1637 |
|
TITLE
|
ECOG 5597: Phase III Chemoprevention Trial of Selenium Supplementation in Persons with Resected Stage I Non-Small Cell Lung Cancer |
| DESCRIPTION
|
This research is being done because it is unknown if taking selenium can prevent the development of second lung cancers. The purpose of the study is to find out if a high selenium yeast tablet can prevent new lung cancers in people with surgically removed non-small cell lung cancer. The selenium will be compared to a placebo yeast tablet.
|
| ELIGIBILITY
|
-
Undergone complete resection of a histologically proven Stage 1A or 1B non-small cell lung cancer and currently free of disease
-
Must be between 6 months and 36 months from date of surgical resection
-
Must not have received chemotherapy or radiotherapy for lung cancer
-
Must be 18 years of age or older
-
Normal hepatic function
-
ECOG performance status of 0-1
-
Must not be taking mineral, herbal, phytochemical, or vitamin supplements at time of entry
|
| CONTACT |
Ann Ness, RN
216-844-1637
|
|
TITLE
|
ECOG
1C99 :
Phase II
Study of Carboplatin plus Paclitaxel Treatment of Advanced
Thymoma or Thymic Carcinoma
|
| DESCRIPTION
|
The
purpose of this study is to determine what effects Carboplatin
and Paclitaxel have on thymoma or thymic cancer
|
| ELIGIBILITY
|
-
Histologically
confirmed invasive, recurrent or metastatic thymoma or
thymic carcinoma not amenable to curative therapy by
surgery
-
Must
have measurable disease
-
No
prior chemotherapy for metastatic disease
-
Adequate
hepatic, renal , and hematologic function
-
Must
be 18 years or older
-
ECOG
performance status of 0 or 1
-
No
acute infection or post-surgical complications
-
Pregnant
or nursing women are excluded
|
| CONTACT
|
Ann Ness, RN
216-844-1637
|
|
TITLE
|
LILY
1502:
ALIMTA Plus Gemcitabine as Front-Line Chemotherapy for
Patients with Malignancy Pleural or Peritoneal Mesothelioma: A
Phase II Clinical Trial
|
| DESCRIPTION
|
This
study will determine the objective response rate for ALIMTA plus
gemcitabine administered in patients with malignant pleural
mesothelioma who have not received prior therapy.
Patients will receive one treatment of gemcitabine on day
1, with on treatment ALIMTA followed immediately by one
treatment of gemcitabine on Day 8 of a 21-day cycle.
Patients may receive up to 6 cycles of therapy.
Further cycles may be administered if the investigator
and Lilly physician determine it is in the best interest of the
patient.
|
| ELIGIBILITY
|
-
Patients
must have histologically confirmed malignant pleural or
peritoneal mesothelioma epithelial, sarcomatoid, or mixed
subtype, not amenable to curative treatment with surgery.
-
Patients
may have undergoing pleurodesis. If pleurodesis was
performed, there must be at least a 2-week delay before
ALIMTA or gemcitabine is administered.
-
Patients
must have an estimated life expectancy of at least 12
weeks.
-
Patients
must have adequate bone marrow, hepatic and renal
function.
-
Patients
must not have received prior systemic chemotherapy.
Prior intracavitary cytotoxic drugs are not
permitted, unless given for the purpose of pleurodesis.
-
Patients
must not have received prior radiation therapy to the
target lesion, unless the lesion is clearly progressi
|