Advanced Non-Small Cell Lung CancerPhase 2NCT00651833
Phase 2 Study of S-1 in Combination With Cisplatin as 1st Line Therapy in Advanced Non-Small Cell Lung Cancer
A Phase 2 study testing S-1 in people with Advanced Non-Small Cell Lung Cancer, run by Taiho Oncology, Inc..
Trial summary
The purpose of this study is to determine whether S-1 in combination with Cisplatin is effective as 1st line therapy in slowing tumor activity in patients with advanced non-small cell lung cancer. The study is also looking at the safety of S-1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Non-Small Cell Lung Cancer
- What is being tested?
- S-1
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Feb 2005to Jul 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- 1. Has given written informed consent. 2. Patients with histologically and/or cytologically proven unresectable NSCLC stage IIIB with pleural effusion or pericardial effusion, or stage IV (mixed forms with small cell lung cancer are excluded).
- 3. Has measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria, ie, has at least one measurable lesion. A measurable lesion is one that can be accurately measured in at least one dimension with the longest diameter ≥ 20 mm using conventional techniques or ≥ 10 mm using spiral Computed Tomography (CT) scan.
- 4. Is able to take medications orally. 5. Is ≥ 18 years of age. 6. Has an ECOG performance status 0 or 1. 7. Has adequate organ function as defined by the following criteria:
- AST (SGOT) and ALT (SGPT) ≤ 2.5 x ULN; if liver function abnormalities are due to underlying liver metastasis AST (SGOT) and ALT (SGPT) ≤ 5 x ULN.
- Total serum bilirubin of ≤ 1.5 x ULN.
- Absolute granulocyte count of ≥ 1,500/mm3.
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- Platelet count ≥ 100,000/mm3.
- Hemoglobin of ≥ 9.0 g/dL.
- Calculated creatinine clearance (CrCl) ≥ 60 mL/minute (Cockcroft-Gault formula).
- 8. Is willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
Who cannot join
- 1. Has had treatment with any of the following within the specified time frame prior to study drug administration:
- Any prior cytotoxic chemotherapy except for adjuvant or neo-adjuvant therapy for NSCLC beyond 12 months.
- Any radiation therapy to a target lesion unless there was evidence of PD after radiotherapy (and this target lesion must not be the only site of measurable disease).
- Radiotherapy within the prior 2 weeks.
- Adjuvant or neo-adjuvant therapy within the past 12 months.
- Prior cisplatin as neo-adjuvant and/or adjuvant chemotherapy with cumulative dose > 300 mg/m2.
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- Any investigational agent, either concurrently or within the past 30 days.
- Current enrollment in another clinical study with an investigational agent. Patients participating in surveys or observational studies are eligible to participate in this study.
- 2. Has a serious illness or medical condition(s) including, but not limited to, the following:
- <!-- -->
- Other active malignancies.
- Symptomatic brain metastasis not controlled by corticosteroids.
- Leptomeningeal metastasis.
- Known neuropathy Grade 2 or higher.
- Myocardial infarction within the last 6 months, severe/unstable angina, congestive heart failure New York Heart Association (NYHA) class III or IV.
- Chronic nausea, vomiting, and/or diarrhea.
- Psychiatric disorder that may interfere with consent and/or protocol compliance.
- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the Investigator would make the patient inappropriate for entry into this study.
- 3. Is receiving concomitant treatment with drugs interacting with S-1. The following drugs are prohibited because there may be an interaction with S-1:
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- Sorivudine, uracil, cimetidine, folinic acid, and dipyridamole (may enhance S-1 activity).
- Allopurinol (may diminish S-1 activity).
- Phenytoin (S-1 may enhance phenytoin activity).
- Flucytosine, a fluorinated pyrimidine antifungal agent (may enhance S-1 activity).4. Is receiving concomitant treatment with drugs interacting with cisplatin. The following drugs are prohibited because there may be an interaction with cisplatin:
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- Phenytoin (cisplatin may diminish phenytoin activity).
- Aminoglycosides (should be avoided within 8 days after cisplatin administration).
- 5. Is a pregnant or lactating female. 6. Has known hypersensitivity to cisplatin. 7. With reproductive potential and refuses to use an adequate means of contraception (including male patients).
About this study
Official title: An Open-Label, Non-Randomized, Multicenter, Three-Stage, Phase 2 Study of S-1 in Combination With Cisplatin as 1st Line Therapy for Patients With Advanced Non-Small Cell Lung Cancer (Stage IIIB/Stage IV)
The purpose of this study is to determine whether S-1 in combination with Cisplatin is effective as 1st line therapy in slowing tumor activity in patients with advanced non-small cell lung cancer. The study is also looking at the safety of S-1.
Read the detailed description
Advanced non-small cell lung cancer is relatively unresponsive to chemotherapy. This is true for the nucleoside analogue gemcitabine, with a response rate of approximately 10%, as well as for 5-fluorouracil (5-FU). Even when gemcitabine is combined with other chemotherapeutic drugs or biological agents, the overall tumor response rate remains basically unchanged. S-1 is a new generation oral fluoropyrimidine that combines Tegafur (5-fluoro-1-(tetrahydro-2-furanyl)-2,4(1H,3H)-pyrimidinedione [FT]), an oral prodrug of 5-FU, with two modulators, Gimeracil (5-chloro-2,4-dihydroxypyridine [CDHP]), which inhibits 5-FU degradation by dihydropyrimidine dehydrogenase (DPD) inhibition, and Oteracil potassium (Oxo), which inhibits 5-FU phosphorylation in the digestive tract. This combination of 3 compounds is designed to achieve enhanced antitumor activity while decreasing gastrointestinal toxicity.
This is an open-label, multicenter, single-arm, 3-stage, Phase 2 study evaluating the efficacy and safety of S-1 in combination with cisplatin as 1st line therapy for patients with advanced NSCLC. The 3 stages of this study correspond to a run-in tolerability stage (stage 1), futility stage (stage 2), and decision stage (stage 3). The run-in tolerability stage will be conducted to assess any additional toxicity associated with a more frequent schedule of administration of cisplatin (75 mg/m2 every 3 weeks) compared with the dosing regimen established in a prior Phase I study in patients with advanced gastric cancer (75 mg/m2 every 4 weeks). The futility stage (stage 2) will be conducted to ensure that this treatment combination is sufficiently efficacious to expose a sufficient number of patients to be able to make a decision (stage 3) on whether this combination treatment warrants further evaluation in future studies.
- Conditions
- Advanced Non-Small Cell Lung Cancer
- Being tested
- S-1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-1Drug
All patients will receive S-1 orally at a dose of 25 mg/m2 twice daily (BID) for 14 days followed by a 1-week recovery period, repeated every 3 weeks. The study may go to the third stage only if 7/31 (23%) or more patients have achieved a confirmed response (CR or PR) in stages 1 and 2 combined.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | All patients will receive S-1 orally at a dose of 25 mg/m2 twice daily (BID) for 14 days followed by a 1-week recovery period, repeated every 3 weeks. Patient will also receive cisplatin, 75 mg/m2 as a 1- to 3-hour infusion on Day 1 of each cycle. Receives: Drug: S-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall tumor response rate (ORR - the proportion of patients with objective evidence of PR or CR)
Measured: Each cycle will last 21 days (14 days treatment, 7 days recovery) for a max of 6 cycles. Tumor assessments will be obtained at baseline and at the end of every even cycle.
Secondary outcomes (3)
To evaluate the safety profile of S-1
Measured: AEs will be reported through follow-up (30 days after the last dose of study medication); blood/urine will be collected at baseline ; Days 8 and 15; w/in 24 hrs prior to study drug on Day 1 of each cycle after Cycle 1; at the end of study treatment.
To evaluate the duration of response (DR), and progression-free survival (PFS)
Measured: Each cycle will last 21 days (14 days treatment, 7 days recovery) for a max of 6 cycles. Following discont'n of treatment , pts will be followed for survival status every 2 mos following PD for up to 6 mos.
To investigate the relationship of S-1 plasma levels (components and metabolites) with safety and efficacy parameters
Measured: Each cycle will last 21 days (14 days treatment, 7 days recovery) for a max of 6 cycles. Blood samples to be obtained 1.5 ± 0.5 h, 5 ± 1 h, 7 ± 1 h postdose on Day 1 of Cycle 1 only.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2008 (estimated)
- Study startFeb 2005
- Primary completionOct 2006
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Taiho Oncology, Inc.The 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taiho Oncology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc., United BioSource, LLC
- Investigators
- Fabio Benedetti, MD, Study director, Taiho Oncology, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00651833
- Sponsor's protocol ID
- TPU-S1202
- Status last verified
- Aug 2024
- First submitted
- 31 Mar 2008
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Non-Randomized, Multicenter, Three-Stage, Phase 2 Study of S-1 in Combination With Cisplatin as 1st Line Therapy for Patients With Advanced Non-Small Cell Lung Cancer (Stage IIIB/Stage IV)
- ClinicalTrials.gov ID
- NCT00651833
- Acronym / sponsor ID
- TPU-S1202
- Conditions
- Advanced Non-Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Taiho Oncology, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc., United BioSource, LLC
- Study start
- Feb 2005
- Primary completion
- Oct 2006 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 3 Apr 2008 (estimated)
- Results
- Not posted in the source record
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 determine whether S-1 in combination with Cisplatin is effective as 1st line therapy in slowing tumor activity in patients with advanced non-small cell lung cancer. The study is also looking at the safety of S-1.
Detailed description
Advanced non-small cell lung cancer is relatively unresponsive to chemotherapy. This is true for the nucleoside analogue gemcitabine, with a response rate of approximately 10%, as well as for 5-fluorouracil (5-FU). Even when gemcitabine is combined with other chemotherapeutic drugs or biological agents, the overall tumor response rate remains basically unchanged. S-1 is a new generation oral fluoropyrimidine that combines Tegafur (5-fluoro-1-(tetrahydro-2-furanyl)-2,4(1H,3H)-pyrimidinedione [FT]), an oral prodrug of 5-FU, with two modulators, Gimeracil (5-chloro-2,4-dihydroxypyridine [CDHP]), which inhibits 5-FU degradation by dihydropyrimidine dehydrogenase (DPD) inhibition, and Oteracil potassium (Oxo), which inhibits 5-FU phosphorylation in the digestive tract. This combination of 3 compounds is designed to achieve enhanced antitumor activity while decreasing gastrointestinal toxicity.
This is an open-label, multicenter, single-arm, 3-stage, Phase 2 study evaluating the efficacy and safety of S-1 in combination with cisplatin as 1st line therapy for patients with advanced NSCLC. The 3 stages of this study correspond to a run-in tolerability stage (stage 1), futility stage (stage 2), and decision stage (stage 3). The run-in tolerability stage will be conducted to assess any additional toxicity associated with a more frequent schedule of administration of cisplatin (75 mg/m2 every 3 weeks) compared with the dosing regimen established in a prior Phase I study in patients with advanced gastric cancer (75 mg/m2 every 4 weeks). The futility stage (stage 2) will be conducted to ensure that this treatment combination is sufficiently efficacious to expose a sufficient number of patients to be able to make a decision (stage 3) on whether this combination treatment warrants further evaluation in future studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: S-1All patients will receive S-1 orally at a dose of 25 mg/m2 twice daily (BID) for 14 days followed by a 1-week recovery period, repeated every 3 weeks. Patient will also receive cisplatin, 75 mg/m2 as a 1- to 3-hour infusion on Day 1 of each cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 1. Has given written informed consent. 2. Patients with histologically and/or cytologically proven unresectable NSCLC stage IIIB with pleural effusion or pericardial effusion, or stage IV (mixed forms with small cell lung cancer are excluded).
- 3. Has measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria, ie, has at least one measurable lesion. A measurable lesion is one that can be accurately measured in at least one dimension with the longest diameter ≥ 20 mm using conventional techniques or ≥ 10 mm using spiral Computed Tomography (CT) scan.
- 4. Is able to take medications orally. 5. Is ≥ 18 years of age. 6. Has an ECOG performance status 0 or 1. 7. Has adequate organ function as defined by the following criteria:
- 8. Is willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
Key exclusion criteria (29 listed)
- 1. Has had treatment with any of the following within the specified time frame prior to study drug administration:
- 2. Has a serious illness or medical condition(s) including, but not limited to, the following:
- <!-- -->
- 3. Is receiving concomitant treatment with drugs interacting with S-1. The following drugs are prohibited because there may be an interaction with S-1:
- <!-- -->
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 |
|---|---|---|
| S-1All patients will receive S-1 orally at a dose of 25 mg/m2 twice daily (BID) for 14 days followed by a 1-week recovery period, repeated every 3 weeks. The study may go to the third stage only if 7/31 (23%) or more patients have achieved a confirmed response (CR or PR) in stages 1 and 2 combined. | Drug | 1 |
Primary outcome
Overall tumor response rate (ORR - the proportion of patients with objective evidence of PR or CR)
Time frame: Each cycle will last 21 days (14 days treatment, 7 days recovery) for a max of 6 cycles. Tumor assessments will be obtained at baseline and at the end of every even cycle.
3 secondary outcomes
To evaluate the safety profile of S-1
Time frame: AEs will be reported through follow-up (30 days after the last dose of study medication); blood/urine will be collected at baseline ; Days 8 and 15; w/in 24 hrs prior to study drug on Day 1 of each cycle after Cycle 1; at the end of study treatment.
To evaluate the duration of response (DR), and progression-free survival (PFS)
Time frame: Each cycle will last 21 days (14 days treatment, 7 days recovery) for a max of 6 cycles. Following discont'n of treatment , pts will be followed for survival status every 2 mos following PD for up to 6 mos.
To investigate the relationship of S-1 plasma levels (components and metabolites) with safety and efficacy parameters
Time frame: Each cycle will last 21 days (14 days treatment, 7 days recovery) for a max of 6 cycles. Blood samples to be obtained 1.5 ± 0.5 h, 5 ± 1 h, 7 ± 1 h postdose on Day 1 of Cycle 1 only.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
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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.
Fabio Benedetti, MD study director
Taiho Oncology, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing S-1 in people with Advanced Non-Small Cell Lung Cancer, run by Taiho Oncology, Inc..
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 10 inclusion and 29 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: finished, as of the sponsor's last update on 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall tumor response rate (ORR - the proportion of patients with objective evidence of PR or CR) (time frame: Each cycle will last 21 days (14 days treatment, 7 days recovery) for a max of 6 cycles. Tumor assessments will be obtained at baseline and at the end of every even cycle.). 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 3 Sep 2024.