A Phase 1/2 interventional study of Docetaxel, Cisplatin and STI571 and Docetaxel in Non-small Cell Lung Cancer, sponsored by Duke University. Terminated. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-09-15.
Sponsored by Duke University · Phase 1/2, Interventional, and Treatment
This is a Phase 1/Phase 2 study of STI571 combined with docetaxel and cisplatin for treatment of patients with recurrent and metastatic Non-Small Cell Lung Cancer (NSCLC).
This research study has 2 parts to it. The first part (Phase 1) is called a dose-escalation. Not all subjects enrolled into this phase of the study will receive the same dose. The purpose of the dose-escalation is to determine the highest safe dose of STI571 that can be used in combination with docetaxel and cisplatin. That dose will be used in Phase 2.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,558 are open to participants now.
This study's enrollment of 43 is below the median of 60 across 5,296 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
Patients with:
Treatment will consist of docetaxel plus cisplatin IV every 21days and oral STI571 given on Days -5 to 2 with each chemotherapy cycle. A maximum of 6 cycles will be given. Phase 1 dose levels are: * Level 1 Docetaxel/Cisplatin 60 mg/m2, STI571 300mg * Level 2 Docetaxel/Cisplatin 60 mg/m2, STI571 400mg * Level 3 Docetaxel/Cisplatin 70 mg/m2, STI571 400mg * Level 4 Docetaxel/Cisplatin 70 mg/m2, STI571 600mg * Level 5 Docetaxel/Cisplatin 75 mg/m2, STI571 600mg * Level 6 Docetaxel/Cisplatin 75 mg/m2, STI571 800mg Once the MTD level has been established, the previous dose level will be the dosing schedule for Phase II.
Also known as: Taxotere, Platinol, Gleevec, Imatinib
Also known as: Taxotere
Also known as: Platinol
Phase 1 - Maximum Tolerated Dose (MTD) of STI571
To determine the maximum tolerated dose (MTD) of STI571, docetaxel, and cisplatin, when administered in combination for the treatment of patients with chemo-naïve recurrent and metastatic (stage IV) NSCLC.
Time frame: After cycle 1, day 22
Phase 1 - Maximum Tolerated Dose (MTD) of Docetaxel and Cisplatin
To determine the maximum tolerated dose (MTD) of STI571, docetaxel, and cisplatin when administered in combination for the treatment of patients with chemo-naïve recurrent and metastatic (stage IV) NSCLC.
Time frame: After cycle 1, day 22
Phase II - Radiographic Response
The percentage of patients with a complete or partial response. Responses for the Phase II portion of the trial will be by Response Evaluation Criteria In Solid Tumors (RECIST) criteria as follows: Complete Response (CR): disappearance of all target lesions; Partial Response (PR): at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Time frame: After Cycle 6, approximately 18 weeks.
Phase 2: 1 Year Survival
Phase II: Percentage of patients alive 1 year from the start of protocol treatment.
Time frame: 1 year
Change in Gd-MRI Measurement
The change in Gd-MRI perfusion/permeability measurement between pre and post 7-day of STI571 treatment.
Time frame: Day 7
Patients with Advanced Non-Small Cell Lung Cancer were enrolled from November 2004 to April 2009. The study was closed due to poor accrual.
| Milestone | Phase 1 | Phase 2 |
|---|---|---|
| Started | 15 | 28 |
| Started study treatment | 15 | 28 |
| Completed | 14 | 28 |
| Not completed | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
To determine the maximum tolerated dose (MTD) of STI571, docetaxel, and cisplatin, when administered in combination for the treatment of patients with chemo-naïve recurrent and metastatic (stage IV) NSCLC.
| mg | Phase 1 |
|---|---|
| Phase 1 - Maximum Tolerated Dose (MTD) of STI571 | 400 |
To determine the maximum tolerated dose (MTD) of STI571, docetaxel, and cisplatin when administered in combination for the treatment of patients with chemo-naïve recurrent and metastatic (stage IV) NSCLC.
| mg/m2 | Phase 1 |
|---|---|
| Docetaxel | 60 |
| Cisplatin | 60 |
Phase II: Percentage of patients alive 1 year from the start of protocol treatment.
| percentage of participants | Phase 2 |
|---|---|
| Phase 2: 1 Year Survival | 61 (40 to 76) |
The change in Gd-MRI perfusion/permeability measurement between pre and post 7-day of STI571 treatment.
No measurements were reported for this outcome.
The percentage of patients with a complete or partial response. Responses for the Phase II portion of the trial will be by Response Evaluation Criteria In Solid Tumors (RECIST) criteria as follows: Complete Response (CR): disappearance of all target lesions; Partial Response (PR): at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
| percentage of participants | Phase 2 |
|---|---|
| Phase II - Radiographic Response | 25 (11 to 45) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Phase 1 | — | 9/15 (60%) | 15/15 (100%) |
| Phase 2 | — | 15/28 (53.6%) | 26/28 (92.9%) |
| Event | Phase 1 | Phase 2 |
|---|---|---|
| Thromboembolic eventVascular disorders | 1/15 | 5/28 |
| DehydrationMetabolism and nutrition disorders | 2/15 | 4/28 |
| Febrile neutropeniaBlood and lymphatic system disorders | 2/15 | 2/28 |
| NauseaGastrointestinal disorders | 2/15 | 2/28 |
| VomitingGastrointestinal disorders | 2/15 | 1/28 |
| Lung infectionInfections and infestations | 1/15 | 3/28 |
| Myocardial infarctionCardiac disorders | 0/15 | 2/28 |
| DiarrheaGastrointestinal disorders | 1/15 | 1/28 |
| Edema faceGeneral disorders | 1/15 | 0/28 |
| FeverGeneral disorders | 1/15 | 0/28 |
| Event | Phase 1 | Phase 2 |
|---|---|---|
| NauseaGastrointestinal disorders | 13/15 | 13/28 |
| FatigueGeneral disorders | 11/15 | 18/28 |
| AnorexiaMetabolism and nutrition disorders | 11/15 | 14/28 |
| AlopeciaSkin and subcutaneous tissue disorders | 11/15 | 17/28 |
| AnemiaBlood and lymphatic system disorders | 7/15 | 17/28 |
| DysgeusiaNervous system disorders | 7/15 | 15/28 |
| ConstipationGastrointestinal disorders | 8/15 | 6/28 |
| HypoalbuminemiaMetabolism and nutrition disorders | 2/15 | 14/28 |
| InsomniaPsychiatric disorders | 7/15 | 8/28 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 7/15 | 6/28 |
All subjects who started study treatment
| Age, Continuous(years) | Phase 1 | Phase 2 | Total |
|---|---|---|---|
| Mean | 52.0 ± 12.5 | 60.0 ± 9.5 | 57.7 ± 11.3 |
| Sex: Female, Male(Participants) | Phase 1 | Phase 2 | Total |
|---|---|---|---|
| Female | 5 | 11 | 16 |
| Male | 10 | 17 | 27 |
| Region of Enrollment(participants) | Phase 1 | Phase 2 | Total |
|---|---|---|---|
| United States | 15 | 28 | 43 |
No study locations are listed for this record.
This study is terminated, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Duke University