Trial Outcomes & Findings for S9912 Combination Chemo in Stage III Ovarian Cancer, (NCT NCT00003896)
NCT ID: NCT00003896
Last Updated: 2013-01-04
Results Overview
From date of registration to date of progression (as defined per RECIST), symptomatic deterioration or death due to any cause.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
68 participants
Primary outcome timeframe
Once a month for 6 months, then every 6 months for up to 2 years, then annually thereafter.
Results posted on
2013-01-04
Participant Flow
Participant milestones
| Measure |
Paclitaxel/CDDP/Lipo Doxorubicin
intravenous paclitaxel (day 1), intraperitoneal cisplatin (day 2), intraperitoneal paclitaxel and intravenous liposomal doxorubicin (day 8)
|
|---|---|
|
Overall Study
STARTED
|
68
|
|
Overall Study
Eligible
|
63
|
|
Overall Study
COMPLETED
|
39
|
|
Overall Study
NOT COMPLETED
|
29
|
Reasons for withdrawal
| Measure |
Paclitaxel/CDDP/Lipo Doxorubicin
intravenous paclitaxel (day 1), intraperitoneal cisplatin (day 2), intraperitoneal paclitaxel and intravenous liposomal doxorubicin (day 8)
|
|---|---|
|
Overall Study
Adverse Event
|
16
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
|
Overall Study
Death
|
3
|
|
Overall Study
not protocol specified
|
3
|
|
Overall Study
ineligible
|
5
|
Baseline Characteristics
S9912 Combination Chemo in Stage III Ovarian Cancer,
Baseline characteristics by cohort
| Measure |
Paclitaxel/CDDP/Lipo Doxorubicin
n=63 Participants
intravenous paclitaxel (day 1), intraperitoneal cisplatin (day 2), intraperitoneal paclitaxel and intravenous liposomal doxorubicin (day 8)
|
|---|---|
|
Age Continuous
|
59 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
63 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
58 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
59 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Once a month for 6 months, then every 6 months for up to 2 years, then annually thereafter.Population: Eligible patients who began the treatment intervention
From date of registration to date of progression (as defined per RECIST), symptomatic deterioration or death due to any cause.
Outcome measures
| Measure |
Paclitaxel/CDDP/Lipo Doxorubicin
n=63 Participants
intravenous paclitaxel (day 1), intraperitoneal cisplatin (day 2), intraperitoneal paclitaxel and intravenous liposomal doxorubicin (day 8)
|
|---|---|
|
Progression-free Survival
|
25 months
Interval 19.0 to 34.0
|
PRIMARY outcome
Timeframe: Weekly for 6 weeks, then every 6 months for 2 years, then annually thereafter.Population: All eligible patients who began the treatment intervention.
from date of registration to date of death due to any cause. Patients last known to be alive wer censored at date of last contact
Outcome measures
| Measure |
Paclitaxel/CDDP/Lipo Doxorubicin
n=63 Participants
intravenous paclitaxel (day 1), intraperitoneal cisplatin (day 2), intraperitoneal paclitaxel and intravenous liposomal doxorubicin (day 8)
|
|---|---|
|
Overall Survival
|
51 months
Interval 42.0 to 59.0
|
SECONDARY outcome
Timeframe: Weekly during 6 weeks of protocol treatmentPopulation: Paclitaxel/CDDP/Liposomal doxorubicin
Only adverse events that are possibly, probably or definitely related to study drug are reported.
Outcome measures
| Measure |
Paclitaxel/CDDP/Lipo Doxorubicin
n=61 Participants
intravenous paclitaxel (day 1), intraperitoneal cisplatin (day 2), intraperitoneal paclitaxel and intravenous liposomal doxorubicin (day 8)
|
|---|---|
|
Adverse Events
Abdominal pain/cramping
|
7 Participants
|
|
Adverse Events
Allergic reaction
|
2 Participants
|
|
Adverse Events
Anemia
|
5 Participants
|
|
Adverse Events
Anorexia
|
5 Participants
|
|
Adverse Events
Ataxia (incoordination)
|
1 Participants
|
|
Adverse Events
Bone pain
|
1 Participants
|
|
Adverse Events
Cardiac ischemia/infarction
|
1 Participants
|
|
Adverse Events
Catheter related infection
|
4 Participants
|
|
Adverse Events
Chest pain,not cardio or pleur
|
1 Participants
|
|
Adverse Events
Confusion
|
1 Participants
|
|
Adverse Events
Constipation/bowel obstruction
|
5 Participants
|
|
Adverse Events
Creatinine increase
|
1 Participants
|
|
Adverse Events
Dehydration
|
5 Participants
|
|
Adverse Events
Diarrhea without colostomy
|
4 Participants
|
|
Adverse Events
Dizziness/light headedness
|
1 Participants
|
|
Adverse Events
Dyspepsia/heartburn
|
1 Participants
|
|
Adverse Events
Dyspnea
|
2 Participants
|
|
Adverse Events
Esophagitis/dysphagia
|
1 Participants
|
|
Adverse Events
Fatigue/malaise/lethargy
|
10 Participants
|
|
Adverse Events
Febrile neutropenia
|
6 Participants
|
|
Adverse Events
GI Mucositis, NOS
|
1 Participants
|
|
Adverse Events
GU fistula
|
1 Participants
|
|
Adverse Events
Hand-foot skin reaction
|
3 Participants
|
|
Adverse Events
Headache
|
1 Participants
|
|
Adverse Events
Hyperglycemia
|
2 Participants
|
|
Adverse Events
Hypertension
|
1 Participants
|
|
Adverse Events
Hypoalbuminemia
|
1 Participants
|
|
Adverse Events
Hypocalcemia
|
1 Participants
|
|
Adverse Events
Hypokalemia
|
4 Participants
|
|
Adverse Events
Hypomagnesemia
|
2 Participants
|
|
Adverse Events
Hypotension
|
1 Participants
|
|
Adverse Events
Ileus
|
2 Participants
|
|
Adverse Events
Infection w/o 3-4 neutropenia
|
5 Participants
|
|
Adverse Events
Infection with 3-4 neutropenia
|
4 Participants
|
|
Adverse Events
Infection, unk ANC
|
2 Participants
|
|
Adverse Events
Insomnia
|
1 Participants
|
|
Adverse Events
Intestinal fistula
|
1 Participants
|
|
Adverse Events
Leukopenia
|
32 Participants
|
|
Adverse Events
Lymphopenia
|
16 Participants
|
|
Adverse Events
Metabolic-other
|
1 Participants
|
|
Adverse Events
Myalgia
|
1 Participants
|
|
Adverse Events
Nausea
|
14 Participants
|
|
Adverse Events
Neutropenia/granulocytopenia
|
35 Participants
|
|
Adverse Events
PRBC transfusion
|
5 Participants
|
|
Adverse Events
Platelet transfusion
|
1 Participants
|
|
Adverse Events
Pneumonitis/infiltrates
|
1 Participants
|
|
Adverse Events
Renal failure
|
1 Participants
|
|
Adverse Events
Respiratory infect w/ neutrop
|
2 Participants
|
|
Adverse Events
SGOT (AST) increase
|
1 Participants
|
|
Adverse Events
SGPT (ALT) increase
|
1 Participants
|
|
Adverse Events
Somnolence/consciousness loss
|
1 Participants
|
|
Adverse Events
Stomatitis/pharyngitis
|
4 Participants
|
|
Adverse Events
Thrombocytopenia
|
5 Participants
|
|
Adverse Events
Thrombosis/embolism
|
4 Participants
|
|
Adverse Events
Urinary tr infect w/o neutrop
|
2 Participants
|
|
Adverse Events
Vomiting
|
9 Participants
|
|
Adverse Events
Weakness (motor neuropathy)
|
3 Participants
|
|
Adverse Events
Weight loss
|
1 Participants
|
Adverse Events
Paclitaxel/CDDP/Liposomal Doxorubicin
Serious events: 2 serious events
Other events: 60 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Paclitaxel/CDDP/Liposomal Doxorubicin
n=61 participants at risk
|
|---|---|
|
Gastrointestinal disorders
GI Mucositis, NOS
|
1.6%
1/61 • Weekly until the end of 6 weeks of protocol treatment.
|
|
Infections and infestations
Infection with 3-4 neutropenia
|
1.6%
1/61 • Weekly until the end of 6 weeks of protocol treatment.
|
|
Infections and infestations
Infection, unk ANC
|
1.6%
1/61 • Weekly until the end of 6 weeks of protocol treatment.
|
|
Investigations
Leukopenia
|
1.6%
1/61 • Weekly until the end of 6 weeks of protocol treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.6%
1/61 • Weekly until the end of 6 weeks of protocol treatment.
|
Other adverse events
| Measure |
Paclitaxel/CDDP/Liposomal Doxorubicin
n=61 participants at risk
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
70.5%
43/61 • Weekly until the end of 6 weeks of protocol treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
9.8%
6/61 • Weekly until the end of 6 weeks of protocol treatment.
|
|
Blood and lymphatic system disorders
PRBC transfusion
|
8.2%
5/61 • Weekly until the end of 6 weeks of protocol treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
6.6%
4/61 • Weekly until the end of 6 weeks of protocol treatment.
|
|
Ear and labyrinth disorders
Inner ear-hearing loss
|
6.6%
4/61 • Weekly until the end of 6 weeks of protocol treatment.
|
|
Gastrointestinal disorders
Abdominal pain/cramping
|
62.3%
38/61 • Weekly until the end of 6 weeks of protocol treatment.
|
|
Gastrointestinal disorders
Constipation/bowel obstruction
|
41.0%
25/61 • Weekly until the end of 6 weeks of protocol treatment.
|
|
Gastrointestinal disorders
Diarrhea without colostomy
|
32.8%
20/61 • Weekly until the end of 6 weeks of protocol treatment.
|
|
Gastrointestinal disorders
Dyspepsia/heartburn
|
8.2%
5/61 • Weekly until the end of 6 weeks of protocol treatment.
|
|
Gastrointestinal disorders
Esophagitis/dysphagia
|
11.5%
7/61 • Weekly until the end of 6 weeks of protocol treatment.
|
|
Gastrointestinal disorders
Nausea
|
73.8%
45/61 • Weekly until the end of 6 weeks of protocol treatment.
|
|
Gastrointestinal disorders
Stomatitis/pharyngitis
|
39.3%
24/61 • Weekly until the end of 6 weeks of protocol treatment.
|
|
Gastrointestinal disorders
Vomiting
|
52.5%
32/61 • Weekly until the end of 6 weeks of protocol treatment.
|
|
General disorders
Edema
|
6.6%
4/61 • Weekly until the end of 6 weeks of protocol treatment.
|
|
General disorders
Fatigue/malaise/lethargy
|
62.3%
38/61 • Weekly until the end of 6 weeks of protocol treatment.
|
|
General disorders
Fever without neutropenia
|
8.2%
5/61 • Weekly until the end of 6 weeks of protocol treatment.
|
|
General disorders
Pain-other
|
11.5%
7/61 • Weekly until the end of 6 weeks of protocol treatment.
|
|
Immune system disorders
Allergic reaction
|
8.2%
5/61 • Weekly until the end of 6 weeks of protocol treatment.
|
|
Infections and infestations
Infection w/o 3-4 neutropenia
|
11.5%
7/61 • Weekly until the end of 6 weeks of protocol treatment.
|
|
Injury, poisoning and procedural complications
Catheter related infection
|
11.5%
7/61 • Weekly until the end of 6 weeks of protocol treatment.
|
|
Injury, poisoning and procedural complications
Local injection site reaction
|
9.8%
6/61 • Weekly until the end of 6 weeks of protocol treatment.
|
|
Investigations
Leukopenia
|
83.6%
51/61 • Weekly until the end of 6 weeks of protocol treatment.
|
|
Investigations
Lymphopenia
|
52.5%
32/61 • Weekly until the end of 6 weeks of protocol treatment.
|
|
Investigations
Neutropenia/granulocytopenia
|
78.7%
48/61 • Weekly until the end of 6 weeks of protocol treatment.
|
|
Investigations
SGOT (AST) increase
|
8.2%
5/61 • Weekly until the end of 6 weeks of protocol treatment.
|
|
Investigations
Thrombocytopenia
|
34.4%
21/61 • Weekly until the end of 6 weeks of protocol treatment.
|
|
Investigations
Weight loss
|
39.3%
24/61 • Weekly until the end of 6 weeks of protocol treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
41.0%
25/61 • Weekly until the end of 6 weeks of protocol treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
18.0%
11/61 • Weekly until the end of 6 weeks of protocol treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
18.0%
11/61 • Weekly until the end of 6 weeks of protocol treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
13.1%
8/61 • Weekly until the end of 6 weeks of protocol treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
11.5%
7/61 • Weekly until the end of 6 weeks of protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.2%
5/61 • Weekly until the end of 6 weeks of protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Chest pain,not cardio or pleur
|
11.5%
7/61 • Weekly until the end of 6 weeks of protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.4%
10/61 • Weekly until the end of 6 weeks of protocol treatment.
|
|
Nervous system disorders
Dizziness/light headedness
|
11.5%
7/61 • Weekly until the end of 6 weeks of protocol treatment.
|
|
Nervous system disorders
Headache
|
13.1%
8/61 • Weekly until the end of 6 weeks of protocol treatment.
|
|
Nervous system disorders
Sensory neuropathy
|
37.7%
23/61 • Weekly until the end of 6 weeks of protocol treatment.
|
|
Nervous system disorders
Taste disturbance
|
18.0%
11/61 • Weekly until the end of 6 weeks of protocol treatment.
|
|
Nervous system disorders
Weakness (motor neuropathy)
|
9.8%
6/61 • Weekly until the end of 6 weeks of protocol treatment.
|
|
Psychiatric disorders
Depression
|
13.1%
8/61 • Weekly until the end of 6 weeks of protocol treatment.
|
|
Psychiatric disorders
Insomnia
|
11.5%
7/61 • Weekly until the end of 6 weeks of protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
14.8%
9/61 • Weekly until the end of 6 weeks of protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/infiltrates
|
6.6%
4/61 • Weekly until the end of 6 weeks of protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
63.9%
39/61 • Weekly until the end of 6 weeks of protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Hand-foot skin reaction
|
23.0%
14/61 • Weekly until the end of 6 weeks of protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
27.9%
17/61 • Weekly until the end of 6 weeks of protocol treatment.
|
|
Vascular disorders
Flushing
|
6.6%
4/61 • Weekly until the end of 6 weeks of protocol treatment.
|
|
Vascular disorders
Hypotension
|
9.8%
6/61 • Weekly until the end of 6 weeks of protocol treatment.
|
|
Vascular disorders
Thrombosis/embolism
|
6.6%
4/61 • Weekly until the end of 6 weeks of protocol treatment.
|
Additional Information
Gynecologic Committee Statistician
SWOG Statistical Center
Phone: 206-667-4623
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place