A Phase 1/2 interventional study of Novel Drug Combination in Small Cell Lung Cancer, Extensive Stage Lung Cancer and Chemonaive, sponsored by University of Alabama at Birmingham. Completed at 2 sites in United States. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2017-07-17.
Sponsored by University of Alabama at Birmingham · Phase 1/2, Interventional, and Treatment
Small cell lung cancer, or SCLC, constitutes approximately 15% of the 170,000 new cases of lung cancer diagnosed annually in the United States. Extensive-stage SCLC comprises two thirds of new cases and is generally considered sensitive to chemotherapy, despite a median time to progression of 4 months. SCLC is one of the most aggressive and lethal types of cancer, with a median survival of 9 months (range 7-11 months) in patients diagnosed with extensive disease. Overall, the majority of patients with SCLC die in less than 2 years (2-year survival rates generally less than 10%), and the 5-year survival rate is 2.3% for patients with extensive disease. The regimen of etoposide in combination with a platinum (cisplatin or carboplatin) is generally considered the "standard of care" although a recent Phase III trial suggests improved survival with the combination of cisplatin/irinotecan. Further evaluation of new agents in combination regimens attempting to overcome the intrinsic drug resistance seen in extensive-stage SCLC is warranted attempting to improve survival and achieve palliation of disease-related symptoms.
We are proposing a novel combination of bendamustine plus irinotecan followed by the standard regimen of etoposide with carboplatin. This will allow the investigation of response to the novel combination as well as any improvement in outcomes compared to historical controls.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,558 are open to participants now.
This study's enrollment of 30 is below the median of 60 across 5,296 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.
Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This novel drug combination includes: Bendamustine, Irinotecan, and Etoposide/Carboplatin. This study has only one arm but it incorporates two phases. Phase I utilizes a combination of bendamustine and irinotecan for Regimen A followed by etoposide and carboplatin for Regimen B.
Drug: Novel Drug Combination
This novel drug combination includes: Bendamustine, Irinotecan, and Etoposide/Carboplatin. Subjects will be treated with irinotecan (150 mg/m2) infusion on Day 1 followed by infusion of bendamustine on Days 1 and 2 at increasing dose levels using a 3+3 design (starting dose of 80-mg/m2/d with 20 mg/mg/d incremental increase to max 120 mg/m2/d) (Regimen A). This will be repeated every 3 weeks for a total of 3 cycles. Restaging for response will be performed prior to the next regimen. * All subjects will then be given carboplatin (AUC 6) on day 1 and etoposide (100 mg/m2) on days 1, 2 and 3 (Regimen B). They will receive 3 cycles of this regimen every 3 weeks prior to restaging. * At the end (3 weeks after) of the sixth total round of chemotherapy, subjects will be re-evaluated for response, and will be followed-up for recurrent disease every 8 weeks.
Also known as: Irinotecan (Camptosar), Carboplatin (Paraplatin), Etoposide (VdPesid), Bendamustine (Treanda)
Number of Participants Experiencing Dose Limiting Toxicity Regimen A - Phase I
The determination of the dose limiting toxicity as defined by The National Cancer Institute Common Toxicity Criteria version 3 as follows: grade 4 neutropenia \>5 days; grade 3/4 febrile neutropenia; grade 4 thrombocytopenia; or grade \>2 non-hematologic toxicities (except for nausea/vomiting, alopecia, or fatigue).
Time frame: 9 weeks
Number of Patients With Adverse Events - Phase II
The degree of toxicity as defined by The National Cancer Institute Common Toxicity Criteria version 3.
Time frame: 9 weeks
Progression Free Survival
Using the Response Evaluation Criteria in Solid Tumors (RECIST 2000), progression is defined as 20% or greater increase from the baseline tumor parameters or new lesions.
Time frame: 7 months
Protocol Open to Accrual: April 2009, Primary Completion Date: May 2015 and Study Completion Date: May 2016. Recruitment location: University of Alabama at Birmingham and Georgia Cancer Specialists.
| Milestone | Phase I - Regimen A: Cohort I (80 mg/m2) - Bendamustine (B) | Phase I - Regimen A: Cohort II 100mg/m2) - (B) | Phase I - Regimen A: Cohort III (120 mg/M2) - (B) | Phase II - Regimen A: Cohort IV (B) 100 -120 mg/m2 (Day 1,2) |
|---|---|---|---|---|
| Started | 3 | 6 | 6 | 15 |
| Maximum tolerated dose | 3 | 6 | 6 | 12 |
| Completed | 3 | 6 | 6 | 12 |
| Not completed | 0 | 0 | 0 | 3 |
| Withdrew: Death | 0 | 0 | 0 | 2 |
| Withdrew: Physician decision | 0 | 0 | 0 | 1 |
| Milestone | Phase I - Regimen A: Cohort I (80 mg/m2) - Bendamustine (B) | Phase I - Regimen A: Cohort II 100mg/m2) - (B) | Phase I - Regimen A: Cohort III (120 mg/M2) - (B) | Phase II - Regimen A: Cohort IV (B) 100 -120 mg/m2 (Day 1,2) |
|---|---|---|---|---|
| Started | 3 | 6 | 6 | 12 |
| Completed | 3 | 6 | 6 | 12 |
| Not completed | 0 | 0 | 0 | 0 |
The determination of the dose limiting toxicity as defined by The National Cancer Institute Common Toxicity Criteria version 3 as follows: grade 4 neutropenia \>5 days; grade 3/4 febrile neutropenia; grade 4 thrombocytopenia; or grade \>2 non-hematologic toxicities (except for nausea/vomiting, alopecia, or fatigue).
| participants | Novel Drug Combination |
|---|---|
| Phase I - Cohort I | 0 |
| Phase I - Cohort II | 1 |
| Phase I - Cohort III | 1 |
The degree of toxicity as defined by The National Cancer Institute Common Toxicity Criteria version 3.
| participants | Novel Drug Combination |
|---|---|
| Number of Patients With Adverse Events - Phase II | 8 |
Using the Response Evaluation Criteria in Solid Tumors (RECIST 2000), progression is defined as 20% or greater increase from the baseline tumor parameters or new lesions.
| months | Novel Drug Combination |
|---|---|
| Progression Free Survival | 6.0 (4.0 to 7.0) |
Collected over 9 Weeks. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Novel Drug Combination | 2/30 (6.7%) | 15/30 (50%) | 15/30 (50%) |
| Event | Novel Drug Combination |
|---|---|
| NeutropeniaBlood and lymphatic system disorders | 15/30 |
| DiarrheaGastrointestinal disorders | 15/30 |
| FatigueGeneral disorders | 10/30 |
| HyperkalemiaMetabolism and nutrition disorders | 6/30 |
| Febrile NeutropeniaInfections and infestations | 4/30 |
| HyponatremiaMetabolism and nutrition disorders | 2/30 |
| HyperglycemiaMetabolism and nutrition disorders | 1/30 |
| PneumonitisRespiratory, thoracic and mediastinal disorders | 1/30 |
| Event | Novel Drug Combination |
|---|---|
| FatigueGeneral disorders | 15/30 |
| DiarrheaGastrointestinal disorders | 11/30 |
| Nausea & VomitingGastrointestinal disorders | 10/30 |
| AnemiaBlood and lymphatic system disorders | 5/30 |
| NeuropathyNervous system disorders | 3/30 |
| ThrombocytopeniaBlood and lymphatic system disorders | 2/30 |
| NeutropeniaBlood and lymphatic system disorders | 1/30 |
| HyperKalemiaMetabolism and nutrition disorders | 1/30 |
| HypocalcemiaMetabolism and nutrition disorders | 1/30 |
| Age, Categorical(Participants) | Regimen A: Cohort I Bendamustine 80 mg/m2 (Day 1,2) | Regimen A: Cohort II Bendamustine 100 mg/m2 (Day 1,2) | Regimen A: Cohort III Bendamustine 120 mg/m2 (Day 1,2) | Regimen A: Cohort IV Bendamustine 100 -120 mg/m2 (Day 1,2) | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 3 | 6 | 5 | 13 | 27 |
| >=65 years | 0 | 0 | 1 | 2 | 3 |
| Sex: Female, Male(Participants) | Regimen A: Cohort I Bendamustine 80 mg/m2 (Day 1,2) | Regimen A: Cohort II Bendamustine 100 mg/m2 (Day 1,2) | Regimen A: Cohort III Bendamustine 120 mg/m2 (Day 1,2) | Regimen A: Cohort IV Bendamustine 100 -120 mg/m2 (Day 1,2) | Total |
|---|---|---|---|---|---|
| Female | 2 | 3 | 2 | 7 | 14 |
| Male | 1 | 3 | 4 | 8 | 16 |
| Region of Enrollment(participants) | Regimen A: Cohort I Bendamustine 80 mg/m2 (Day 1,2) | Regimen A: Cohort II Bendamustine 100 mg/m2 (Day 1,2) | Regimen A: Cohort III Bendamustine 120 mg/m2 (Day 1,2) | Regimen A: Cohort IV Bendamustine 100 -120 mg/m2 (Day 1,2) | Total |
|---|---|---|---|---|---|
| United States | 3 | 6 | 6 | 15 | 30 |
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2017. 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.
University of Alabama at Birmingham