Pemetrexed &Oxaliplatin in Patients w Recurrent NSCLCa After Failure to Platinum Based Adjuvant Chem
The purpose of this study is:
- To find out if the chemotherapy treatment using Pemetrexed (Alimta) and Oxaliplatin (Eloxatin) given together will kill the cancer cells in the patient's body and shrink the size of their tumor. This may allow patients to live longer or decrease the frequency and/or severity of the symptoms caused by the cancer. Pemetrexed has been approved by the Food and Drug Administration (FDA) to treat Lung Cancer. Oxaliplatin has been approved by the FDA for the treatment of Colon Cancer. The combination of these two drugs has been used to treat patients with Non-Small Cell Lung Cancer in Italy but not yet in the USA
Other purposes of this study are:
- To better detail the toxic effects of this chemotherapy combination.
- To determine whether the level of specific gene and/or gene products (genes are genetic material that allows cells to make proteins such as enzymes) are useful to predict if this chemotherapy combination will work or not.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Combination of Pemetrexed and Oxaliplatin in Patients With Recurrent Non-Small Cell Lung Cancer After Failure to Platinum Based Adjuvant Chemotherapy|
- Number of Patients Who Responded to Treatment [ Time Frame: Patient will continue study treatment until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 3 weeks. ] [ Designated as safety issue: No ]We planned to determine the Overall Response Rate (ORR = CR+PR) of this regimen according to RECIST Criteria.
- Time to Progression (TTP) [ Time Frame: Patient will continue study treatment until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 3 weeks. ] [ Designated as safety issue: No ]We planned to calculate the median Time to Progression of all participants.
- Number of Participants Who Experienced Toxicities [ Time Frame: Patient will continue study treatment until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 3 weeks. ] [ Designated as safety issue: Yes ]We planned to determine the safety of the regimen (Drug Toxicities) assessed by NCI Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0)
|Study Start Date:||June 2007|
|Study Completion Date:||January 2008|
|Primary Completion Date:||January 2008 (Final data collection date for primary outcome measure)|
Experimental: Premetrexed and Oxaliplatin
Patients will be treated with oxaliplatin 120 mg/m^2 i.v. over 2 hours and pemetrexed 500 mg/m^2 i.v. over 10 minutes on Day 1 of a 21day cycle. Cycles of treatment will be repeated every 3 weeks. Folic acid and B12 supplementation is obligatory.
Dose Regimen: 120 mg/m^2 on Days 1 every 21 days
Other Name: Eloxatin™Drug: Pemetrexed
Dose Regimen: 500 mg/m^2 on Days 1 every 21 days
Other Name: Alimta™
This is a non-randomized, two stage design, open-label Phase II trial in newly diagnosed patients with advanced or metastatic NSCLC who have previously received and failed adjuvant platinum-based chemotherapy for early stage, resected NSCLC.
Correlative Studies; Molecular correlative studies (genomic and proteomic) are included in this protocol. Prior to chemotherapy, all patients will undergo a biopsy of the safest and/or most accessible site of tumor in order to obtain tissue for mRNA measurements. Additionally, patients will undergo blood sampling prior to the start of chemotherapy and after 2 and 4 cycles of therapy in order to obtain plasma for the mass spectrometry analysis.
Patients, whose second and/or third specimen cannot be collected for any reason, will remain in the trial, and treatment will continue as outlined in the protocol.
Expected Number of Patients:
The number of patients was calculated according to the procedure described in the Sample Size Calculation section of the protocol. It is estimated that up to 50 patients will be enrolled to obtain the 43 evaluable patients needed to meet the statistical design of the study.
Method of Treatment Allocation:
A patient number will be assigned sequentially to each patient upon registration. The patient number and the patient initials are to be entered on each page of the Case Report Form.
Duration of Study for Each Patient:
All patients will be treated with up to 6 cycles of chemotherapy. However, at the discretion of the treating physician and principle investigator, patients may continue chemotherapy, beyond 6 cycles, until disease progression, intolerable toxicity, or the development of any study removal criteria. Patients will undergo an evaluation for extent of disease after every other treatment cycle.
Patients will be considered to be on-study for the duration of their treatment and during the 30 days following treatment discontinuation. Treatment discontinuation is defined as the last day of study treatment. All included patients will be followed up until recovery or stabilization of all adverse events or return to baseline condition. Patients who discontinue from the trial prior to experiencing disease progression will be followed monthly until demonstration of progressive disease.
The H. Lee Moffitt Cancer Center will conduct this trial through the Moffitt Clinical Research Affiliate Network. Patients will be evaluated and the biopsy will be performed at the H. Lee Moffitt Cancer Center. Since all the chemotherapeutic drugs used in the protocol are FDA approved, and phase I and II safety data regarding this regimen has been published30,31, the chemotherapy may be administered at the patients' primary (referring) oncologists' office. Documentation of the administration of the chemotherapy will be obtained for record keeping purposes.
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Alberto Chiappori, M.D.||H. Lee Moffitt Cancer Center and Research Institute|