Trial Outcomes & Findings for Paclitaxel in Treating Patients With Ovarian Stromal Cancer (NCT NCT00006227)
NCT ID: NCT00006227
Last Updated: 2020-03-05
Results Overview
The probability of complete clinical response (i.e. proportion of participants) (assessed using GOG RECIST criteria) of paclitaxel as second line chemotherapy in measurable disease patients with malignant tumors of the ovarian stroma
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
31 participants
Primary outcome timeframe
Up to 5 years
Results posted on
2020-03-05
Participant Flow
Participant milestones
| Measure |
Treatment (Paclitaxel)
Patients receive paclitaxel IV over 3 hours on day 1. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity.
Paclitaxel: Given IV
|
|---|---|
|
Overall Study
STARTED
|
31
|
|
Overall Study
COMPLETED
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Paclitaxel in Treating Patients With Ovarian Stromal Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Paclitaxel)
n=31 Participants
Patients receive paclitaxel IV over 3 hours on day 1. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity.
Paclitaxel: Given IV
|
|---|---|
|
Age, Customized
< 40
|
7 participants
n=93 Participants
|
|
Age, Customized
40-49
|
8 participants
n=93 Participants
|
|
Age, Customized
50-59
|
9 participants
n=93 Participants
|
|
Age, Customized
>= 60
|
7 participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Up to 5 yearsPopulation: Eligible and evaluable
The probability of complete clinical response (i.e. proportion of participants) (assessed using GOG RECIST criteria) of paclitaxel as second line chemotherapy in measurable disease patients with malignant tumors of the ovarian stroma
Outcome measures
| Measure |
Treatment (Paclitaxel)
n=31 Participants
Patients receive paclitaxel IV over 3 hours on day 1. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity.
Paclitaxel: Given IV
|
|---|---|
|
Probability of Complete Clinical Response
|
3.2 Percentage of Participants
Interval 0.74 to 15.3
|
SECONDARY outcome
Timeframe: The period from study entry until disease progression, death or date of last contactDuration of progression free survival (median) (months)
Outcome measures
| Measure |
Treatment (Paclitaxel)
n=31 Participants
Patients receive paclitaxel IV over 3 hours on day 1. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity.
Paclitaxel: Given IV
|
|---|---|
|
Progression-free Survival
|
10.0 Months
Interval 6.0 to 19.6
|
SECONDARY outcome
Timeframe: The observed length of life from entry into the study to death or the date of last contactDuration of overall survival (median) (months)
Outcome measures
| Measure |
Treatment (Paclitaxel)
n=31 Participants
Patients receive paclitaxel IV over 3 hours on day 1. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity.
Paclitaxel: Given IV
|
|---|---|
|
Overall Survival
|
73.6 Months
Interval 63.7 to 112.9
|
Adverse Events
Treatment (Paclitaxel)
Serious events: 1 serious events
Other events: 31 other events
Deaths: 16 deaths
Serious adverse events
| Measure |
Treatment (Paclitaxel)
n=31 participants at risk
Patients receive paclitaxel IV over 3 hours on day 1. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity.
Paclitaxel: Given IV
|
|---|---|
|
Investigations
Neutrophil count decreased
|
3.2%
1/31 • Number of events 1 • For the duration of treatment and follow-up
Adverse events were defined according to CTC v2.0 for the period of protocol activation through March 31, 2010. Beginning on April 1, 2010 adverse events were defined according to CTCAE v4.0.
|
|
Investigations
White blood cell decreased
|
3.2%
1/31 • Number of events 1 • For the duration of treatment and follow-up
Adverse events were defined according to CTC v2.0 for the period of protocol activation through March 31, 2010. Beginning on April 1, 2010 adverse events were defined according to CTCAE v4.0.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
3.2%
1/31 • Number of events 1 • For the duration of treatment and follow-up
Adverse events were defined according to CTC v2.0 for the period of protocol activation through March 31, 2010. Beginning on April 1, 2010 adverse events were defined according to CTCAE v4.0.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.2%
1/31 • Number of events 1 • For the duration of treatment and follow-up
Adverse events were defined according to CTC v2.0 for the period of protocol activation through March 31, 2010. Beginning on April 1, 2010 adverse events were defined according to CTCAE v4.0.
|
|
General disorders
Injection site reaction
|
3.2%
1/31 • Number of events 1 • For the duration of treatment and follow-up
Adverse events were defined according to CTC v2.0 for the period of protocol activation through March 31, 2010. Beginning on April 1, 2010 adverse events were defined according to CTCAE v4.0.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.2%
1/31 • Number of events 1 • For the duration of treatment and follow-up
Adverse events were defined according to CTC v2.0 for the period of protocol activation through March 31, 2010. Beginning on April 1, 2010 adverse events were defined according to CTCAE v4.0.
|
Other adverse events
| Measure |
Treatment (Paclitaxel)
n=31 participants at risk
Patients receive paclitaxel IV over 3 hours on day 1. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity.
Paclitaxel: Given IV
|
|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
61.3%
19/31 • For the duration of treatment and follow-up
Adverse events were defined according to CTC v2.0 for the period of protocol activation through March 31, 2010. Beginning on April 1, 2010 adverse events were defined according to CTCAE v4.0.
|
|
Blood and lymphatic system disorders
Neutropenia
|
67.7%
21/31 • For the duration of treatment and follow-up
Adverse events were defined according to CTC v2.0 for the period of protocol activation through March 31, 2010. Beginning on April 1, 2010 adverse events were defined according to CTCAE v4.0.
|
|
Blood and lymphatic system disorders
Anemia
|
64.5%
20/31 • For the duration of treatment and follow-up
Adverse events were defined according to CTC v2.0 for the period of protocol activation through March 31, 2010. Beginning on April 1, 2010 adverse events were defined according to CTCAE v4.0.
|
|
Investigations
Thrombocytopenia
|
19.4%
6/31 • For the duration of treatment and follow-up
Adverse events were defined according to CTC v2.0 for the period of protocol activation through March 31, 2010. Beginning on April 1, 2010 adverse events were defined according to CTCAE v4.0.
|
|
Immune system disorders
Allergic reaction
|
12.9%
4/31 • For the duration of treatment and follow-up
Adverse events were defined according to CTC v2.0 for the period of protocol activation through March 31, 2010. Beginning on April 1, 2010 adverse events were defined according to CTCAE v4.0.
|
|
Cardiac disorders
Cardiovascular
|
12.9%
4/31 • For the duration of treatment and follow-up
Adverse events were defined according to CTC v2.0 for the period of protocol activation through March 31, 2010. Beginning on April 1, 2010 adverse events were defined according to CTCAE v4.0.
|
|
General disorders
Constitutional
|
58.1%
18/31 • For the duration of treatment and follow-up
Adverse events were defined according to CTC v2.0 for the period of protocol activation through March 31, 2010. Beginning on April 1, 2010 adverse events were defined according to CTCAE v4.0.
|
|
Skin and subcutaneous tissue disorders
Dermatologic
|
71.0%
22/31 • For the duration of treatment and follow-up
Adverse events were defined according to CTC v2.0 for the period of protocol activation through March 31, 2010. Beginning on April 1, 2010 adverse events were defined according to CTCAE v4.0.
|
|
Gastrointestinal disorders
Gastrointestinal
|
58.1%
18/31 • For the duration of treatment and follow-up
Adverse events were defined according to CTC v2.0 for the period of protocol activation through March 31, 2010. Beginning on April 1, 2010 adverse events were defined according to CTCAE v4.0.
|
|
Renal and urinary disorders
Genitourinary
|
12.9%
4/31 • For the duration of treatment and follow-up
Adverse events were defined according to CTC v2.0 for the period of protocol activation through March 31, 2010. Beginning on April 1, 2010 adverse events were defined according to CTCAE v4.0.
|
|
Hepatobiliary disorders
Hepatic
|
16.1%
5/31 • For the duration of treatment and follow-up
Adverse events were defined according to CTC v2.0 for the period of protocol activation through March 31, 2010. Beginning on April 1, 2010 adverse events were defined according to CTCAE v4.0.
|
|
Infections and infestations
Infection / fever
|
12.9%
4/31 • For the duration of treatment and follow-up
Adverse events were defined according to CTC v2.0 for the period of protocol activation through March 31, 2010. Beginning on April 1, 2010 adverse events were defined according to CTCAE v4.0.
|
|
Injury, poisoning and procedural complications
Neurologic
|
67.7%
21/31 • For the duration of treatment and follow-up
Adverse events were defined according to CTC v2.0 for the period of protocol activation through March 31, 2010. Beginning on April 1, 2010 adverse events were defined according to CTCAE v4.0.
|
|
Metabolism and nutrition disorders
Metabolic
|
19.4%
6/31 • For the duration of treatment and follow-up
Adverse events were defined according to CTC v2.0 for the period of protocol activation through March 31, 2010. Beginning on April 1, 2010 adverse events were defined according to CTCAE v4.0.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
19.4%
6/31 • For the duration of treatment and follow-up
Adverse events were defined according to CTC v2.0 for the period of protocol activation through March 31, 2010. Beginning on April 1, 2010 adverse events were defined according to CTCAE v4.0.
|
|
Eye disorders
Ocular
|
19.4%
6/31 • For the duration of treatment and follow-up
Adverse events were defined according to CTC v2.0 for the period of protocol activation through March 31, 2010. Beginning on April 1, 2010 adverse events were defined according to CTCAE v4.0.
|
|
General disorders
Pain
|
71.0%
22/31 • For the duration of treatment and follow-up
Adverse events were defined according to CTC v2.0 for the period of protocol activation through March 31, 2010. Beginning on April 1, 2010 adverse events were defined according to CTCAE v4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
9.7%
3/31 • For the duration of treatment and follow-up
Adverse events were defined according to CTC v2.0 for the period of protocol activation through March 31, 2010. Beginning on April 1, 2010 adverse events were defined according to CTCAE v4.0.
|
Additional Information
Christopher Purdy on behalf of Mark Brady PhD
NRG Oncology
Phone: (716)845-1300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60