Phase II Combination of Pemetrexed and Oxaliplatin in Patients With Recurrent Non-Small Cell Lung Cancer After Failure to Platinum Based Adjuvant Chemotherapy
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
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
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
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Patients Who Responded to Treatment
We planned to determine the Overall Response Rate (ORR = CR+PR) of this regimen according to RECIST Criteria.
Patient will continue study treatment until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 3 weeks.
Alberto Chiappori, M.D.
H. Lee Moffitt Cancer Center and Research Institute
United States: Institutional Review Board
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