A Phase 2 interventional study of Sunitinib Malate Continuous Daily Dosing and Sunitinib Malate Schedule 4/2 in Carcinoma, Renal Cell, sponsored by Pfizer. Completed at 159 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-09-05.
Sponsored by Pfizer · Phase 2, Interventional, and Treatment
This trial has two parts. The purpose of the first part of the trial is to determine the doses of 2 drugs, sunitinib malate and interferon alfa-2b, that can be given safely in combination. This part is currently closed to enrollment.
The purpose of the second part of the trial is to see if sunitinib malate given on a 4/2 schedule (4 weeks on treatment, 2 weeks off treatment cycle) is any better at delaying progression of renal cell cancer than sunitinib malate given on a continuous dosing schedule. The trial will also determine the number of patients whose cancer responds to the treatments, whether life of patients can be extended, what the side effects are of the treatments, how bothersome disease or treatment-related symptoms are to patients, and whether tests can be found that will predict which patients may or may not respond to these treatments in the future.
1,965 studies on the registry are indexed under Carcinoma, Renal Cell; 378 are open to participants now.
This study's enrollment of 317 is above the median of 42 across 1,480 interventional studies indexed under Carcinoma, Renal Cell.
Browse Carcinoma, Renal Cell studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Drug: Sunitinib Malate Continuous Daily Dosing
Drug: Sunitinib Malate Schedule 4/2
Sunitinib malate starting dose 37.5 mg daily continuous daily regimen.
Sunitinib malate starting dose 50 mg per day for four weeks, followed by a two week off-drug period. This six week cycle is repeated.
Time to Tumor Progression (TTP) Assessed Using Memorial Sloan-Kettering Cancer Center (MSKCC) Prognostic Factors Model
MSKCC Prognostic Factor Model assessed as low(0),intermediate(1-2) or high(=\>3) based on number of criteria present such as Karnofsky performance status \< 80 %, Lactate dehydrogenase \> 1.5 \* Upper limit of Normal,Hemoglobin \< lower limit of normal, serum calcium \> 10 mg/dL;Time from first diagnosis of renal cell carcinoma to start of systemic therapy of \< 1 year.TTP was time from start of study treatment to first documentation of objective tumor progression or death due to cancer.TTP was calculated as (first event date minus date of first dose of study medication plus 1) divided by 30.44.
Time frame: From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years
Percentage of Participants With Objective Response (OR)
Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with atleast 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Time frame: From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years
Duration of Response (DR)
Time from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.44. DR was calculated for the subgroup of participants with a confirmed objective tumor response.
Time frame: From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years
Overall Survival (OS) Assessed Using MSKCC Prognostic Factors Model
MSKCC Prognostic Factor Model assessed as low (0), intermediate (1-2) or high (=\>3) based upon number of criteria present. Criteria as follows: Karnofsky performance status \< 80 %, Lactate dehydrogenase \> 1.5 \* Upper limit of Normal, Hemoglobin \< lower limit of normal for local lab, Corrected serum calcium \> 10 mg/dL; Time from first diagnosis of renal cell carcinoma to start of systemic therapy of \< 1 year. OS was defined as time from date of start of treatment to date of death due to any cause. OS, in months, was calculated as (event date -start of treatment date + 1)/30.44.
Time frame: From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years
Functional Assessment of Cancer Therapy-General (FACT-G)
FACT-G is core questionnaire of Functional Assessment of Chronic Illness Therapy (FACIT) measurement system to evaluate quality of life (QoL) in cancer population.FACT-G consisted of 27 questions grouped in 4 domains of general Health-Related QoL(HRQoL):Physical Well-being(PWB),Social/Family Well-Being (SWB),Emotional Well-Being (EWB) and Functional Well-Being (FWB);each ranging from 0 (not at all) to 4 (very much) so that FACT-G ranged between 0-108.Since questions could be reversed coded, as appropriate, before calculating FACT-G,0 and 108 could be considered worst and best health states.
Time frame: From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years
FACT-Kidney Symptom Index for Disease Related Symptoms (FKSI-DRS)
FKSI-DRS is a subset of FKSI which is a questionnaire for Functional Assessment of Cancer Therapy -Kidney Symptom Index used to assess QoL/participant-reported outcomes for participants diagnosed with renal cell cancer. The FKSI contained 15 questions and the FKSI-DRS consisted of 9 questions each ranging from 0 (not at all) to 4 (very much) so that FKSI-DRS ranged between 0-36. Since the questions could be reversed coded, as appropriate, before calculating FKSI-DRS, 0 and 36 could be considered the worst and best health states based on the 9 questions comprising FKSI-DRS.
Time frame: From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years
| Milestone | Sunitinib 37.5 mg + Interferon Alpha-2b | Sunitinib 50 mg (Schedule 4/2) | Sunitinib 37.5 mg |
|---|---|---|---|
| Started | 25 | 0 | 0 |
| Completed | 2 | 0 | 0 |
| Not completed | 23 | 0 | 0 |
| Withdrew: Progressive disease | 10 | 0 | 0 |
| Withdrew: Adverse event | 8 | 0 | 0 |
| Withdrew: Death | 1 | 0 | 0 |
| Withdrew: Participant not willing to participate | 1 | 0 | 0 |
| Withdrew: Other | 3 | 0 | 0 |
| Milestone | Sunitinib 37.5 mg + Interferon Alpha-2b | Sunitinib 50 mg (Schedule 4/2) | Sunitinib 37.5 mg |
|---|---|---|---|
| Started | 0 | 146 | 146 |
| Treated | 0 | 146 | 143 |
| Completed | 0 | 19 | 14 |
| Not completed | 0 | 127 | 132 |
| Withdrew: Death | 0 | 2 | 3 |
| Withdrew: Adverse event | 0 | 23 | 25 |
| Withdrew: Global deterioration of health status | 0 | 6 | 7 |
| Withdrew: Lost to follow-up | 0 | 1 | 0 |
| Withdrew: Objective progression or relapse | 0 | 77 | 86 |
| Withdrew: Withdrawal by subject | 0 | 9 | 2 |
| Withdrew: Other | 0 | 9 | 6 |
| Withdrew: Randomized but not treated | 0 | 0 | 3 |
MSKCC Prognostic Factor Model assessed as low(0),intermediate(1-2) or high(=\>3) based on number of criteria present such as Karnofsky performance status \< 80 %, Lactate dehydrogenase \> 1.5 \* Upper limit of Normal,Hemoglobin \< lower limit of normal, serum calcium \> 10 mg/dL;Time from first diagnosis of renal cell carcinoma to start of systemic therapy of \< 1 year.TTP was time from start of study treatment to first documentation of objective tumor progression or death due to cancer.TTP was calculated as (first event date minus date of first dose of study medication plus 1) divided by 30.44.
| Months | Sunitinib 50 mg (Schedule 4/2) | Sunitinib 37.5 mg |
|---|---|---|
| Stratified analysis : High Risk (=>3) | 3.1 (0.5 to 10.4) | 4.4 (1.4 to 7.1) |
| Stratified analysis : Intermediate Risk (1-2) | 8.0 (5.1 to 11.1) | 7.1 (5.5 to 10.0) |
| Stratified analysis : Low Risk (0) | 20.7 (9.9 to 25.2) | 8.4 (7.0 to 21.0) |
| Overall unstratified analysis | 9.9 (7.0 to 13.4) | 7.1 (6.8 to 9.7) |
Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with atleast 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
| Percentage of participants | Sunitinib 50 mg (Schedule 4/2) | Sunitinib 37.5 mg |
|---|---|---|
| Percentage of Participants With Objective Response (OR) | 32.2 (24.7 to 40.4) | 28.1 (21.0 to 36.1) |
Time from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.44. DR was calculated for the subgroup of participants with a confirmed objective tumor response.
| Months | Sunitinib 50 mg (Schedule 4/2) | Sunitinib 37.5 mg |
|---|---|---|
| Duration of Response (DR) | 12.5 (1.9 to 23.4) | 8.7 (1.2 to 22.4) |
MSKCC Prognostic Factor Model assessed as low (0), intermediate (1-2) or high (=\>3) based upon number of criteria present. Criteria as follows: Karnofsky performance status \< 80 %, Lactate dehydrogenase \> 1.5 \* Upper limit of Normal, Hemoglobin \< lower limit of normal for local lab, Corrected serum calcium \> 10 mg/dL; Time from first diagnosis of renal cell carcinoma to start of systemic therapy of \< 1 year. OS was defined as time from date of start of treatment to date of death due to any cause. OS, in months, was calculated as (event date -start of treatment date + 1)/30.44.
| Months | Sunitinib 50 mg (Schedule 4/2) | Sunitinib 37.5 mg |
|---|---|---|
| High Risk (equal or more than 3) | 3.5 (1.1 to 21.2) | 6.1 (3.6 to 15.1) |
| Intermediate Risk (1-2) | 19.3 (14.0 to 24.7) | 21.8 (14.5 to NA) |
| Low Risk (0) | NA (24.4 to NA) | 28.9 (28.9 to NA) |
FACT-G is core questionnaire of Functional Assessment of Chronic Illness Therapy (FACIT) measurement system to evaluate quality of life (QoL) in cancer population.FACT-G consisted of 27 questions grouped in 4 domains of general Health-Related QoL(HRQoL):Physical Well-being(PWB),Social/Family Well-Being (SWB),Emotional Well-Being (EWB) and Functional Well-Being (FWB);each ranging from 0 (not at all) to 4 (very much) so that FACT-G ranged between 0-108.Since questions could be reversed coded, as appropriate, before calculating FACT-G,0 and 108 could be considered worst and best health states.
| Units on a scale | Sunitinib 50 mg (Schedule 4/2) | Sunitinib 37.5 mg |
|---|---|---|
| Functional Assessment of Cancer Therapy-General (FACT-G) | 78.0 ± 15.9 | 77.0 ± 17.1 |
FKSI-DRS is a subset of FKSI which is a questionnaire for Functional Assessment of Cancer Therapy -Kidney Symptom Index used to assess QoL/participant-reported outcomes for participants diagnosed with renal cell cancer. The FKSI contained 15 questions and the FKSI-DRS consisted of 9 questions each ranging from 0 (not at all) to 4 (very much) so that FKSI-DRS ranged between 0-36. Since the questions could be reversed coded, as appropriate, before calculating FKSI-DRS, 0 and 36 could be considered the worst and best health states based on the 9 questions comprising FKSI-DRS.
| Units on scale | Sunitinib 50 mg (Schedule 4/2) | Sunitinib 37.5 mg |
|---|---|---|
| FACT-Kidney Symptom Index for Disease Related Symptoms (FKSI-DRS) | 28.3 ± 5.6 | 27.2 ± 5.9 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sunitinib 37.5 mg + Interferon Alpha-2b | — | 7/25 (28%) | 25/25 (100%) |
| Sunitinib 50 mg (Schedule 4/2) | — | 50/146 (34.2%) | 144/146 (98.6%) |
| Sunitinib 37.5 mg | — | 54/143 (37.8%) | 142/143 (99.3%) |
| Event | Sunitinib 37.5 mg + Interferon Alpha-2b | Sunitinib 50 mg (Schedule 4/2) | Sunitinib 37.5 mg |
|---|---|---|---|
| DehydrationMetabolism and nutrition disorders | 1/25 | 6/146 | 12/143 |
| Disease progressionGeneral disorders | 0/25 | 7/146 | 11/143 |
| AnaemiaBlood and lymphatic system disorders | 1/25 | 3/146 | 2/143 |
| Myocardial infarctionCardiac disorders | 1/25 | 0/146 | 0/143 |
| Gastrointestinal haemorrhageGastrointestinal disorders | 1/25 | 3/146 | 3/143 |
| CholecystitisHepatobiliary disorders | 1/25 | 1/146 | 2/143 |
| Haemoglobin decreasedInvestigations | 1/25 | 0/146 | 0/143 |
| HypercalcaemiaMetabolism and nutrition disorders | 1/25 | 2/146 | 0/143 |
| HypocalcaemiaMetabolism and nutrition disorders | 1/25 | 0/146 | 0/143 |
| HypoglycaemiaMetabolism and nutrition disorders | 1/25 | 0/146 | 2/143 |
| Event | Sunitinib 37.5 mg + Interferon Alpha-2b | Sunitinib 50 mg (Schedule 4/2) | Sunitinib 37.5 mg |
|---|---|---|---|
| FatigueGeneral disorders | 25/25 | 94/146 | 100/143 |
| DiarrhoeaGastrointestinal disorders | 20/25 | 85/146 | 98/143 |
| NauseaGastrointestinal disorders | 14/25 | 91/146 | 76/143 |
| NeutropeniaBlood and lymphatic system disorders | 14/25 | 24/146 | 19/143 |
| StomatitisGastrointestinal disorders | 13/25 | 32/146 | 33/143 |
| Decreased appetiteMetabolism and nutrition disorders | 11/25 | 46/146 | 59/143 |
| DyspepsiaGastrointestinal disorders | 10/25 | 37/146 | 36/143 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 10/25 | 29/146 | 26/143 |
| DysgeusiaNervous system disorders | 7/25 | 55/146 | 49/143 |
| ThrombocytopeniaBlood and lymphatic system disorders | 9/25 | 35/146 | 28/143 |
| Age Continuous(Years) | Sunitinib 37.5 mg + Interferon Alpha-2b | Sunitinib 50 mg (Schedule 4/2) | Sunitinib 37.5 mg | Total |
|---|---|---|---|---|
| Mean | 62.4 ± 7.2 | 60.4 ± 9.8 | 64.3 ± 9.7 | 62.4 ± 9.7 |
| Sex: Female, Male(Participants) | Sunitinib 37.5 mg + Interferon Alpha-2b | Sunitinib 50 mg (Schedule 4/2) | Sunitinib 37.5 mg | Total |
|---|---|---|---|---|
| Female | 5 | 45 | 57 | 107 |
| Male | 20 | 101 | 89 | 210 |
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