Lung CancerPhase 2NCT00612677
Pemetrexed &Oxaliplatin in Patients w Recurrent NSCLCa After Failure to Platinum Based Adjuvant Chem
A Phase 2 study testing Oxaliplatin and Pemetrexed in people with Lung Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Oxaliplatin and Pemetrexed
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Jan 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of completely resected NSCLC and adjuvant/neoadjuvant chemotherapy with platinum-based regimen
- Histologically/cytologically confirmed recurrence of NSCLC after curative therapy with surgery and adjuvant/neoadjuvant chemotherapy
- Must have measurable disease according to RECIST criteria
- ECOG Performance Score of 0-2 determined within 2 weeks prior to enrollment
- Expected survival > 12 weeks
- Adequate bone marrow function,as evidenced by:
Show all 19Show fewer
- Absolute neutrophil count (ANC) > 1,500/µL
- Platelet count > 100,000/µL
- Hemoglobin > 8 g/dL (determined within 2 weeks prior to enrollment)
- Adequate renal function evidenced by:
- serum creatinine < 1.5 mg/dL OR
- calculated creatinine clearance >45 mL/min.
- Adequate hepatic function evidenced by:
- Serum total bilirubin < 1.5 mg/dL OR less than the upper limit of normal (ULN)
- Alkaline phosphatase < 3X the ULN for the reference lab (< 5X the ULN for patients with known hepatic or bony metastases)
- SGOT/SGPT < 3X the ULN for the reference lab (< 5X the ULN for patients with known hepatic metastases)
- Must be recovered from both acute and late effects of any prior surgery, radiotherapy, other antineoplastic therapy
- Signed informed written consent
- Patients of childbearing potential and their partners must agree to use an effective form of contraception during the study and for 90 days following last dose of study medication
Who cannot join
- Patients amenable to a "curative intent" therapeutic approach (re-resection with or without preoperative or postoperative therapy or chemoradiotherapy without surgery are not eligible for this study).
- An active infection or with fever > 101.00 F within 3 days of first scheduled day of protocol treatment
- Active CNS metastases. Patients with stable CNS disease, who have undergone radiotherapy (or surgery ± radiotherapy) at least 4 weeks prior to planned first protocol treatment and who have been on stable or decreasing dose of corticosteroids for >2 weeks are eligible
- Prior malignancy within the past 5 years except for curatively treated basal cell carcinoma of the skin, cervical intra-epithelial neoplasia, or localized prostate cancer with a current PSA of < 1.0 mg/dL on 2 successive evaluations, at least 3 months apart, with most recent evaluation no more than 4 weeks prior to entry.
- Any diagnosis of NSCLC occurring after 5 years of curative therapy (surgery plus adjuvant chemotherapy) for original NSCLC will be considered a second primary rather than a recurrence and will render patient ineligible for this study. An exception will be if both tumors are considered the same after a direct pathologic comparison if both, sponsor and investigator agree.
- Patients that at discretion of the PI have a second primary rather than metastasis are not eligible
Show all 14Show fewer
- Known hypersensitivity to any of the components of oxaliplatin or pemetrexed.
- Patients receiving concurrent investigational therapy or who have received investigational therapy within 30 days of the first scheduled day of protocol treatment
- Patients who received radiotherapy to more than 33% of their bone marrow or received any radiotherapy within 4 weeks of entry
- Peripheral neuropathy ≥ Grade 2
- Patients pregnant or lactating
- Any other medical condition, including mental illness or substance abuse, deemed likely to interfere with patient's ability to sign informed consent, cooperate and participate in the study, or interfere with interpretation of the results.
- History of allogeneic transplant
- Known history of HIV or Hepatitis B or C infection. Patients with Hepatitis B carrier status only are eligible.
Trial locations and contacts
1 site in 1 country.
United States1 site
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
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
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
Read more
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.
Read the detailed description
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.
- Conditions
- Lung Cancer
- Being tested
- Oxaliplatin, Pemetrexed
- Keywords
- recurrent, non-small cell
- Medical subject headings
- Lung Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxaliplatinDrug
Also called Eloxatin™
Dose Regimen: 120 mg/m^2 on Days 1 every 21 days
PemetrexedDrug
Also called Alimta™
Dose Regimen: 500 mg/m^2 on Days 1 every 21 days
| Study group | Role | What they receive |
|---|---|---|
| Premetrexed and Oxaliplatin | Experimental | 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. Receives: Drug: Oxaliplatin; Drug: Pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Patient will continue study treatment until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 3 weeks.
Secondary outcomes (2)
Time to Progression (TTP)
We planned to calculate the median Time to Progression of all participants.
Measured: 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)
Measured: Patient will continue study treatment until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 3 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2008 (estimated)
- Study startJun 2007
- Primary completionJan 2008
- Study completionJan 2008
Why it stopped: slow accrual - the 1 patient accrued did not go on treatment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Alberto Chiappori, M.D., Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00612677
- Sponsor's protocol ID
- MCC-15010
- Other IDs
- OX-04-006
- Status last verified
- Dec 2013
- First submitted
- 29 Jan 2008
- Last updated
- 23 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00612677
- Acronym / sponsor ID
- MCC-15010
- Conditions
- Lung Cancer
- Keywords
- recurrent, non-small cell
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow accrual - the 1 patient accrued did not go on treatment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Jun 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 12 Feb 2008 (estimated)
- Results
- Posted 20 Apr 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Premetrexed and Oxaliplatin | Experimental | Drug: Oxaliplatin, Drug: PemetrexedPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- History of completely resected NSCLC and adjuvant/neoadjuvant chemotherapy with platinum-based regimen
- Histologically/cytologically confirmed recurrence of NSCLC after curative therapy with surgery and adjuvant/neoadjuvant chemotherapy
- Must have measurable disease according to RECIST criteria
- ECOG Performance Score of 0-2 determined within 2 weeks prior to enrollment
- Expected survival > 12 weeks
Key exclusion criteria (14 listed)
- Patients amenable to a "curative intent" therapeutic approach (re-resection with or without preoperative or postoperative therapy or chemoradiotherapy without surgery are not eligible for this study).
- An active infection or with fever > 101.00 F within 3 days of first scheduled day of protocol treatment
- Active CNS metastases. Patients with stable CNS disease, who have undergone radiotherapy (or surgery ± radiotherapy) at least 4 weeks prior to planned first protocol treatment and who have been on stable or decreasing dose of corticosteroids for >2 weeks are eligible
- Prior malignancy within the past 5 years except for curatively treated basal cell carcinoma of the skin, cervical intra-epithelial neoplasia, or localized prostate cancer with a current PSA of < 1.0 mg/dL on 2 successive evaluations, at least 3 months apart, with most recent evaluation no more than 4 weeks prior to entry.
- Any diagnosis of NSCLC occurring after 5 years of curative therapy (surgery plus adjuvant chemotherapy) for original NSCLC will be considered a second primary rather than a recurrence and will render patient ineligible for this study. An exception will be if both tumors are considered the same after a direct pathologic comparison if both, sponsor and investigator agree.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxaliplatinAlso: Eloxatin™Dose Regimen: 120 mg/m^2 on Days 1 every 21 days | Drug | Premetrexed and Oxaliplatin |
| PemetrexedAlso: Alimta™Dose Regimen: 500 mg/m^2 on Days 1 every 21 days | Drug | Premetrexed and Oxaliplatin |
Primary outcome
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.
We planned to determine the Overall Response Rate (ORR = CR+PR) of this regimen according to RECIST Criteria.
2 secondary outcomes
Time to Progression (TTP)
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
Time frame: Patient will continue study treatment until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 3 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alberto Chiappori, M.D. principal investigator
H. Lee Moffitt Cancer Center and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxaliplatin and Pemetrexed in people with Lung Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Apr 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2017.