A Phase 2 interventional study of Oxaliplatin and Pemetrexed in Lung Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-23.
Sponsored by H. Lee Moffitt Cancer Center and Research Institute · Phase 2, Interventional, and Treatment
The purpose of this study is:
Other purposes of this study are:
Treatment Plan:
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.
Study Centers:
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.
7,333 studies on the registry are indexed under Lung Neoplasms; 1,554 are open to participants now.
This study's enrollment of 1 is below the median of 60 across 5,345 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →H. Lee Moffitt Cancer Center and Research Institute is the lead sponsor of 539 studies on the registry; 74 are open to participants now.
Of its 99 completed or terminated interventional studies of FDA-regulated products, 57 (58%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Adequate bone marrow function,as evidenced by:
Adequate renal function evidenced by:
Adequate hepatic function evidenced by:
Exclusion Criteria:
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.
Drug: Oxaliplatin · Drug: Pemetrexed
Dose Regimen: 120 mg/m\^2 on Days 1 every 21 days
Also known as: Eloxatin™
Dose Regimen: 500 mg/m\^2 on Days 1 every 21 days
Also known as: Alimta™
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.
Time frame: Patient will continue study treatment until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 3 weeks.
Time to Progression (TTP)
We planned to calculate the median Time to Progression of all participants.
Time frame: Patient will continue study treatment until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 3 weeks.
Number of Participants Who Experienced Toxicities
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)
Time frame: Patient will continue study treatment until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 3 weeks.
| Milestone | Chemotherapy |
|---|---|
| Started | 1 |
| Completed | 0 |
| Not completed | 1 |
| Withdrew: Study closed before treatment started | 1 |
We planned to determine the Overall Response Rate (ORR = CR+PR) of this regimen according to RECIST Criteria.
No measurements were reported for this outcome.
We planned to calculate the median Time to Progression of all participants.
No measurements were reported for this outcome.
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)
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Chemotherapy | — | 0/1 (0%) | 0/1 (0%) |
| Age, Categorical(Participants) | Chemotherapy |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 0 |
| >=65 years | 1 |
| Sex: Female, Male(Participants) | Chemotherapy |
|---|---|
| Female | 0 |
| Male | 1 |
| Region of Enrollment(participants) | Chemotherapy |
|---|---|
| United States | 1 |
This study is terminated, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Oxaliplatin · Pemetrexed
H. Lee Moffitt Cancer Center and Research Institute →