Neoadjuvant Platinum-based Chemotherapy for Patients With Resectable , Non-small Cell Lung Cancer With Switch to Chemotherapy Alternative in Nonresponders (NEOSCAN)
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| ClinicalTrials.gov Identifier: NCT01443078 |
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Recruitment Status :
Completed
First Posted : September 29, 2011
Results First Posted : August 9, 2016
Last Update Posted : August 9, 2018
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The purpose of this study is to test a new approach to the use of standard drugs before surgery in patients with lung cancer. This study will find out what effects, good and/or bad, that this approach has on the cancer.
It is routine to give chemotherapy prior to surgery in patients with this type of lung cancer, to help keep it from coming back. It is also routine to perform a special type of scan called a PET scan. This PET scan measures how active a cancer is by use of a special tracer made out of sugar. In this study, all patients will have a PET scan and then be treated with standard chemotherapy drugs, either pemetrexed and cisplatin if the cancer is a "non-squamous" cancer or gemcitabine and cisplatin if the cancer is a squamous cancer. In rare cases, the doctor will decide to give carboplatin instead of cisplatin. In most patients, a repeat PET scan will show that the tumor is decreasing and they will complete standard chemotherapy then go on to have surgery.
In some patients, a repeat PET scan will show that the tumor has not decreased enough. For these patients, the routine practice is to proceed with surgery. This research study will test whether switching from the standard treatment of pemetrexed and cisplatin or gemcitabine and cisplatin to a different treatment called vinorelbine and docetaxel is safe and effective. Vinorelbine and docetaxel are also standard chemotherapy drugs which work in a different way than pemetrexed or gemcitabine and cisplatin.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lung Cancer | Drug: pemetrexed Drug: cisplatin Drug: Carboplatin Drug: Gemcitabine Hydrochloride Drug: Vinorelbine Tartrate Drug: Docetaxel | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 42 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Phase II Trial of Neoadjuvant Platinum-based Chemotherapy for Patients With Resectable , Non-small Cell Lung Cancer With Switch to Chemotherapy Alternative in Nonresponders (NEOSCAN) |
| Study Start Date : | October 2011 |
| Actual Primary Completion Date : | April 2015 |
| Actual Study Completion Date : | April 2015 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: pemetrexed plus cisplatin, vinorelbine and docetaxel
This is a phase 2 clinical trial for patients with clinical Stage IB-III resectable and operable non-small cell lung cancer, evaluating whether the switch to an alternative, non-platinum neoadjuvant chemotherapy is safe and effective in patients who do not respond to neoadjuvant platinum-based chemotherapy. Those who fail to respond to platinum-based chemotherapy will be switched to the alternative neoadjuvant chemotherapy vinorelbine 45 mg/m2 and docetaxel 45 mg/m2 on day 1 followed by pegylated filgrastim on day 2, repeated every 2 weeks for 4 doses, followed by repeat FDG PET and CT scan.
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Drug: pemetrexed Drug: cisplatin Drug: Carboplatin Drug: Gemcitabine Hydrochloride Drug: Vinorelbine Tartrate Drug: Docetaxel |
- PERCIST Partial Metabolic Response [ Time Frame: 2 years ]The primary endpoint was partial metabolic response after 2 cycles of "switch" therapy as assessed by PERCIST (SUVmax decrease ≥30% using the pre-switch scan as new baseline).
- Pathologic Response Rate [ Time Frame: 2 years ]The percentage of patients with a major pathologic response
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Pathologic confirmation of NSCLC at MSKCC
- Stages IB, IIA, IIB, IIIA or IIIB NSCLC
- Primary tumor must measure ≥ 2 cm on CT imaging (per PERCIST guidelines)
- Primary tumor must be FDG-avid with an SUVmax >4.5 (to be consistent with PERCIST guidelines)
- Patients must be candidates for resection with curative intent
- Age ≥ 18 years
- Karnofsky performance status ≥ 70%
- Normal bone marrow function
- leukocytes ≥ 3,000/μl
- absolute neutrophil count ≥ 1,500/μl
- platelets ≥100,000/μl
- hemoglobin ≥9gm/dl.
- Adequate hepatic function
- Total bilirubin ≤1.5 x ULN
- AST ≤ 1.5 x UNL, ALT ≤ 1.5 x ULN
- Alkaline phosphatase ≤ 1.5x ULN
- Women of childbearing age must have a negative pregnancy test
- Men and women of childbearing potential must be willing to use effective contraception while on treatment and for at least 3 months thereafter
- Patients must have the ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
- Patients must not be receiving any other investigational agents
- History of myocardial infarction or unstable angina within the past 12 months Patients with peripheral neuropathy > grade 1
- Other serious illness or medical condition including unstable cardiac disease requiring treatment, history of significant neurologic or psychiatric disorders (including psychotic disorders, dementia, or seizures), or active uncontrolled infection.
- Patients with diabetes mellitus requiring insulin therapy (per PERCIST guidelines)
- Patients with third space fluid which cannot be adequately controlled with drainage
- Women who are pregnant or breast-feeding
- Psychiatric illness or social situation that would limit compliance with study requirements
- Patients with known HIV infection requiring antiretroviral medications and those with AIDS
- Baseline subjective hearing deficit, even if it does not require a hearing aid or intervention, or interfere with activities of daily living (CTCAE grade 2 or higher)
- Baseline renal function <60 ml/min as calculated by the equation of Cockcroft and Gault using the patient's age, weight (kg), and serum creatinine (mg/dl).
- Congestive heart failure with New York Heart Association functional classification > II, characterized by fatigue, dyspnea or other symptoms which limit activities of daily life.
Selection of Pemetrexed versus Gemcitabine: Patients treated with pemetrexed must meet all of the following criteria:
- Non-squamous histology
- Patients must have the ability to interrupt non-steroidal anti-inflammatory drugs (NSAIDs) 2 days before (5 days for long-acting NSAIDs), the day of, and 2 days following administration of pemetrexed
- Patients must have the ability to take folic acid, Vitamin B12, and dexamethasone according to protocol
- Patient refuses to take cisplatin
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01443078
| United States, New Jersey | |
| Memoral Sloan Kettering Cancer Center | |
| Basking Ridge, New Jersey, United States | |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center @ Suffolk | |
| Commack, New York, United States, 11725 | |
| Memorial Sloan Kettering Cancer Center | |
| New York, New York, United States, 10065 | |
| Memorial Sloan-Kettering at Mercy Medical Center | |
| Rockville Centre, New York, United States | |
| Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center | |
| Sleepy Hollow, New York, United States, 10591 | |
| Principal Investigator: | Jamie E. Chaft, MD | Memorial Sloan Kettering Cancer Center |
| Responsible Party: | Memorial Sloan Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01443078 |
| Other Study ID Numbers: |
11-106 |
| First Posted: | September 29, 2011 Key Record Dates |
| Results First Posted: | August 9, 2016 |
| Last Update Posted: | August 9, 2018 |
| Last Verified: | July 2018 |
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Carboplatin Cisplatin Pemetrexed (Altima) Taxotere (Docetaxel) Vinorelbine Tartrate (Navelbine) |
Stage IB-III non squamous non-small cell lung cancer 11-106 |
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Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Gemcitabine Carboplatin Docetaxel Pemetrexed Vinorelbine |
Antineoplastic Agents Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Tubulin Modulators Antimitotic Agents Mitosis Modulators Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |