A Phase 2 interventional study of Laboratory Biomarker Analysis and Pegylated Irinotecan in Recurrent Small Cell Lung Carcinoma, sponsored by Roswell Park Cancer Institute. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-17.
Sponsored by Roswell Park Cancer Institute · Phase 2, Interventional, and Treatment
This phase II trial studies how well pegylated irinotecan NKTR 102 works in treating patients with small cell lung cancer that has returned after a period of improvement. Pegylated irinotecan NKTR 102 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. To evaluate the 18-week progression free survival (PFS) rate of relapsed small cell lung cancer (SCLC) patients treated with NKTR-102 (pegylated irinotecan NKTR 102).
SECONDARY OBJECTIVES:
I. To evaluate the objective response rate. II. To evaluate the duration of response. III. To evaluate the overall survival. IV. To evaluate the toxicity of NKTR-102 in this patient population.
TERTIARY OBJECTIVES:
I. To explore the correlation between UDP glucuronosyltransferase 1 family, polypeptide A cluster (UGTIA1) polymorphisms and NKTR-102 toxicities.
OUTLINE:
Patients receive pegylated irinotecan NKTR 102 intravenously (IV) over 90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days and then every 3 months thereafter.
1,203 studies on the registry are indexed under Small Cell Lung Carcinoma; 342 are open to participants now.
This study's enrollment of 38 is below the median of 56 across 1,031 interventional studies indexed under Small Cell Lung Carcinoma.
Browse Small Cell Lung Carcinoma studies →Roswell Park Cancer Institute is the lead sponsor of 412 studies on the registry; 62 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 21 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients receive pegylated irinotecan NKTR 102 IV over 90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Other: Laboratory Biomarker Analysis · Drug: Pegylated Irinotecan · Other: Pharmacological Study
Correlative studies
Given IV
Also known as: NKTR 102, PEG-Irinotecan
Correlative studies
18 Week Progression-free Survival Rate
The distribution of time to disease progression will be estimated in each group using the method of Kaplan-Meier at 18 weeks.
Time frame: Time from registration to the date of first documented disease progression or death, assessed at 18 weeks
Objective Tumor Response Measured With Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Objective tumor response will be tabulated overall (and by dose level if appropriate). Responses will be summarized by simple descriptive summary statistics delineating complete and partial responses as well as stable and progressive disease in the cohorts (overall and by tumor group).
Time frame: Up to 30 days
Mean Duration of Response
The mean duration of response for those participants that responded to treatment by arm.
Time frame: Time from registration to death due to any cause, assessed up to 3 years
Best Response
Count of participants by best response, defined as best objective status recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since treatment started), measured by RECIST 1.1 Tumor response is defined as a complete response (CR) or partial response (PR) by RECIST 1.1 criteria, which will be evaluated by CT scan every other cycle. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: Up to 30 days
Median Overall Survival
The distribution of survival time was be estimated in each group using the method of Kaplan-Meier.
Time frame: Time from registration to death due to any cause, assessed up to 3 years
Incidence of Adverse Events, Assessed Using NCI CTCAE v 4.0
Count of participants by maximum graded according to NCI CTCAE v 4.0 of any adverse event by arm. Please refer to the adverse event reporting for more detail.
Time frame: Up to 30 days
| Milestone | A: Chemo Resistant | B: Chemo Sensitive |
|---|---|---|
| Started | 20 | 18 |
| Completed | 18 | 12 |
| Not completed | 2 | 6 |
| Withdrew: Death | 0 | 1 |
| Withdrew: Withdrawal by subject | 1 | 2 |
| Withdrew: Physician decision | 1 | 3 |
The distribution of time to disease progression will be estimated in each group using the method of Kaplan-Meier at 18 weeks.
| percentage of participants | A: Chemo Resistant | B: Chemo Sensitive |
|---|---|---|
| 18 Week Progression-free Survival Rate | 35 (16 to 55) | 72 (46 to 87) |
Objective tumor response will be tabulated overall (and by dose level if appropriate). Responses will be summarized by simple descriptive summary statistics delineating complete and partial responses as well as stable and progressive disease in the cohorts (overall and by tumor group).
| percentage of participants | A: Chemo Resistant | B: Chemo Sensitive |
|---|---|---|
| Objective Tumor Response Measured With Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 | 20 (6 to 44) | 39 (17 to 64) |
The mean duration of response for those participants that responded to treatment by arm.
| months | A: Chemo Resistant | B: Chemo Sensitive |
|---|---|---|
| Mean Duration of Response | 5.4 ± 3.8 | 7.0 ± 6.8 |
Count of participants by best response, defined as best objective status recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since treatment started), measured by RECIST 1.1 Tumor response is defined as a complete response (CR) or partial response (PR) by RECIST 1.1 criteria, which will be evaluated by CT scan every other cycle. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
| Participants | A: Chemo Resistant | B: Chemo Sensitive |
|---|---|---|
| CR Complete Response/Remission | 0 | 1 |
| PR Partial Response/Remission | 4 | 6 |
| SD Stable Disease | 6 | 7 |
| PD Progressive Disease | 9 | 2 |
| NE Not Evaluable | 1 | 2 |
The distribution of survival time was be estimated in each group using the method of Kaplan-Meier.
| months | A: Chemo Resistant | B: Chemo Sensitive |
|---|---|---|
| Median Overall Survival | 7.4 (2.9 to 11.7) | 7.1 (4.8 to 14.7) |
Count of participants by maximum graded according to NCI CTCAE v 4.0 of any adverse event by arm. Please refer to the adverse event reporting for more detail.
| Participants | A: Chemo Resistant | B: Chemo Sensitive |
|---|---|---|
| Grade 1 | 7 | 1 |
| Grade 2 | 3 | 6 |
| Grade 3 | 9 | 9 |
| Grade 4 | 0 | 1 |
| Grade 5 | 0 | 1 |
| Grade 0 | 1 | 0 |
Collected over From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| A: Chemo Resistant | 0/20 (0%) | 4/20 (20%) | 19/20 (95%) |
| B: Chemo Sensitive | 1/18 (5.6%) | 4/18 (22.2%) | 17/18 (94.4%) |
| Event | A: Chemo Resistant | B: Chemo Sensitive |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 2/20 | 0/18 |
| Pericardial effusionCardiac disorders | 0/20 | 1/18 |
| Gastric ulcer perforationGastrointestinal disorders | 0/20 | 1/18 |
| Hip fractureInjury, poisoning and procedural complications | 0/20 | 1/18 |
| Muscular weaknessMusculoskeletal and connective tissue disorders | 0/20 | 1/18 |
| DiverticulitisInfections and infestations | 1/20 | 0/18 |
| Renal failure acuteRenal and urinary disorders | 1/20 | 0/18 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 1/20 | 0/18 |
| Event | A: Chemo Resistant | B: Chemo Sensitive |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 10/20 | 12/18 |
| NauseaGastrointestinal disorders | 7/20 | 10/18 |
| FatigueGeneral disorders | 7/20 | 7/18 |
| Decreased appetiteMetabolism and nutrition disorders | 3/20 | 7/18 |
| Weight decreasedInvestigations | 7/20 | 4/18 |
| VomitingGastrointestinal disorders | 6/20 | 5/18 |
| White blood cell count decreasedInvestigations | 6/20 | 3/18 |
| AnaemiaBlood and lymphatic system disorders | 5/20 | 3/18 |
| Abdominal painGastrointestinal disorders | 3/20 | 4/18 |
| HaemoglobinInvestigations | 1/20 | 4/18 |
All treated and eligible patients
| Age, Categorical(Participants) | A: Chemo Resistant | B: Chemo Sensitive | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 14 | 11 | 25 |
| >=65 years | 6 | 7 | 13 |
| Age, Continuous(years) | A: Chemo Resistant | B: Chemo Sensitive | Total |
|---|---|---|---|
| Mean | 60.5 ± 8.7 | 61.9 ± 7.9 | 61.2 ± 8.3 |
| Sex: Female, Male(Participants) | A: Chemo Resistant | B: Chemo Sensitive | Total |
|---|---|---|---|
| Female | 10 | 9 | 19 |
| Male | 10 | 9 | 19 |
| Race (NIH/OMB)(Participants) | A: Chemo Resistant | B: Chemo Sensitive | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 20 | 17 | 37 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 1 | 1 |
| ECOG performance status(Participants) | A: Chemo Resistant | B: Chemo Sensitive | Total |
|---|---|---|---|
| Grade 0 | 9 | 8 | 17 |
| Grade 1 | 11 | 10 | 21 |
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Roswell Park Cancer Institute