Trial Outcomes & Findings for Sunitinib in Recurrent and Refractory Ovarian, Fallopian Tube and Peritoneal Carcinoma (NCT NCT00768144)
NCT ID: NCT00768144
Last Updated: 2018-08-24
Results Overview
Best response on treatment was based on RECIST 1.0 criteria with overall response defined as achieving partial response (PR) or complete response (CR). Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
COMPLETED
PHASE2
36 participants
Clinical assessments were performed weekly for first 4 weeks and every 2 wks in subsequent cycles. Disease was evaluated radiologically at baseline, before each odd cycle and at end of trt.
2018-08-24
Participant Flow
Participants were recruited from the GYN Oncology clinics at the DFCI, MGH and BIDMC. Thirty six consenting participants were enrolled over a 19 month period.
Participant milestones
| Measure |
Sunitinib
Patients received oral Sunitinib at the daily dose of 37.5 mg continuously over a 28- day treatment cycle. Treatment continued until clinical or radiological evidence of progressive disease or excessive toxicity.
|
|---|---|
|
Overall Study
STARTED
|
36
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
36
|
Reasons for withdrawal
| Measure |
Sunitinib
Patients received oral Sunitinib at the daily dose of 37.5 mg continuously over a 28- day treatment cycle. Treatment continued until clinical or radiological evidence of progressive disease or excessive toxicity.
|
|---|---|
|
Overall Study
Adverse Event
|
13
|
|
Overall Study
Progressive Disease
|
21
|
|
Overall Study
Patient or MD Decision to End Treatment
|
1
|
|
Overall Study
Pt Withdrew Consent
|
1
|
Baseline Characteristics
Sunitinib in Recurrent and Refractory Ovarian, Fallopian Tube and Peritoneal Carcinoma
Baseline characteristics by cohort
| Measure |
Sunitinib
n=36 Participants
Patients received oral Sunitinib at the daily dose of 37.5 mg continuously over a 28- day treatment cycle. Treatment continued until clinical or radiological evidence of progressive disease or excessive toxicity.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=5 Participants
|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=5 Participants
|
|
Histology
Papillary serous
|
23 participants
n=5 Participants
|
|
Histology
Endometrioid
|
2 participants
n=5 Participants
|
|
Histology
Clear cell
|
5 participants
n=5 Participants
|
|
Histology
Mixed Mullerian tumor
|
3 participants
n=5 Participants
|
|
Histology
Other (adenocarcinoma/mixed histology)
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Clinical assessments were performed weekly for first 4 weeks and every 2 wks in subsequent cycles. Disease was evaluated radiologically at baseline, before each odd cycle and at end of trt.Population: The analysis dataset is comprised of all treated patients.
Best response on treatment was based on RECIST 1.0 criteria with overall response defined as achieving partial response (PR) or complete response (CR). Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
Outcome measures
| Measure |
Sunitinib
n=36 Participants
Patients received oral Sunitinib at the daily dose of 37.5 mg continuously over a 28- day treatment cycle. Treatment continued until clinical or radiological evidence of progressive disease or excessive toxicity.
|
|---|---|
|
Overall Response Rate
|
.083 proportion of participants
Interval 0.024 to 0.21
|
SECONDARY outcome
Timeframe: Clinical assessments were performed weekly for first 4 weeks and every 2 weeks in subsequent cycles. Disease was evaluated radiologically at baseline, before each odd cycle and at end of treatment.Population: The analysis dataset is comprised of all treated patients.
16-week progression-free survival is the probability of patients remaining alive and progression-free at 16-weeks from study entry estimated using Kaplan-Meier methods. Patients alive and progression-free at last follow-up are censored. Progressive disease (PD) based on RECIST 1.0 is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or equivocal progression of non-target lesions.
Outcome measures
| Measure |
Sunitinib
n=36 Participants
Patients received oral Sunitinib at the daily dose of 37.5 mg continuously over a 28- day treatment cycle. Treatment continued until clinical or radiological evidence of progressive disease or excessive toxicity.
|
|---|---|
|
16-Week Progression-Free Survival
|
.36 probability
Interval 0.2 to 0.52
|
SECONDARY outcome
Timeframe: Clinical assessments were performed weekly for first 4 weeks and every 2 weeks in subsequent cycles. Disease was evaluated radiologically at baseline, before each odd cycle and at end of treatment.Population: The analysis dataset is comprised of all treated patients.
Progression-free survival estimated using Kaplan-Meier methods is defined as the time from registration to the earlier of death or disease progression. Patients alive without disease progression are censored at the date of last disease evaluation. Progressive disease (PD) based on RECIST 1.0 is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Equivocal progression of non-target lesions also qualifies as PD.
Outcome measures
| Measure |
Sunitinib
n=36 Participants
Patients received oral Sunitinib at the daily dose of 37.5 mg continuously over a 28- day treatment cycle. Treatment continued until clinical or radiological evidence of progressive disease or excessive toxicity.
|
|---|---|
|
Progression-Free Survival
|
9.9 weeks
Interval 7.1 to 16.4
|
Adverse Events
Sunitinib
Serious adverse events
| Measure |
Sunitinib
n=36 participants at risk
Sunitinib : Taken orally once a day in the evening
|
|---|---|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.8%
1/36 • Number of events 1 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
|
|
Gastrointestinal disorders
Small bowel obstruction
|
5.6%
2/36 • Number of events 2 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
|
|
Nervous system disorders
Cerebrovascular accident
|
2.8%
1/36 • Number of events 1 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
|
|
Immune system disorders
Allergic reaction
|
2.8%
1/36 • Number of events 1 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.8%
1/36 • Number of events 1 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
|
|
General disorders
Death due to progressive disease
|
2.8%
1/36 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
|
Other adverse events
| Measure |
Sunitinib
n=36 participants at risk
Sunitinib : Taken orally once a day in the evening
|
|---|---|
|
Vascular disorders
Hypertension
|
100.0%
36/36 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
|
|
General disorders
Fatigue
|
100.0%
36/36 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
|
|
Gastrointestinal disorders
Vomiting
|
100.0%
36/36 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
|
|
Blood and lymphatic system disorders
Anemia
|
22.2%
8/36 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
|
|
Investigations
White blood cell increased
|
30.6%
11/36 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
|
|
Investigations
Platelet count decreased
|
44.4%
16/36 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
|
|
Investigations
Weight loss
|
5.6%
2/36 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
11.1%
4/36 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
63.9%
23/36 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
36/36 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
|
|
Gastrointestinal disorders
Taste disturbance
|
30.6%
11/36 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
|
|
Investigations
Alkaline phosphatase increased
|
11.1%
4/36 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
|
|
Investigations
Neutrophil count decreased
|
33.3%
12/36 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
25.0%
9/36 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
|
|
Gastrointestinal disorders
Constipation
|
22.2%
8/36 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
|
|
Renal and urinary disorders
Proteinuria
|
100.0%
36/36 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
|
|
Gastrointestinal disorders
Abdominal bloating
|
8.3%
3/36 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
9/36 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
|
|
Nervous system disorders
Headache
|
100.0%
36/36 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
12/36 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
|
|
Investigations
Creatinine increased
|
5.6%
2/36 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
19.4%
7/36 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
11.1%
4/36 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
3/36 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.1%
4/36 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
|
|
Gastrointestinal disorders
Mucositis
|
61.1%
22/36 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
|
|
Investigations
Bilirubin increased
|
5.6%
2/36 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
19.4%
7/36 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.3%
3/36 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
|
|
Psychiatric disorders
Depression
|
5.6%
2/36 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
|
|
Investigations
Alanine aminotransferase increased
|
22.2%
8/36 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
|
|
Renal and urinary disorders
Urinary frequency
|
8.3%
3/36 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.6%
2/36 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
19.4%
7/36 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.3%
3/36 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
13.9%
5/36 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
8.3%
3/36 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.3%
3/36 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
13.9%
5/36 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.7%
6/36 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
|
|
Vascular disorders
CNS cerebrovascular ischemia
|
5.6%
2/36 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
|
|
Investigations
White blood cell decreased
|
11.1%
4/36 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
|
|
Nervous system disorders
Neuropathy
|
19.4%
7/36 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
5.6%
2/36 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
8.3%
3/36 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
|
|
Renal and urinary disorders
Urine color
|
5.6%
2/36 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.9%
5/36 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
8.3%
3/36 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.3%
3/36 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
|
|
Endocrine disorders
Hypothyroidism
|
8.3%
3/36 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place