Trial Outcomes & Findings for Carboplatin Plus Paclitaxel With or Without Continued Low-Dose Paclitaxel in Treating Patients With Early-Stage Ovarian Cancer (NCT NCT00003644)
NCT ID: NCT00003644
Last Updated: 2019-06-04
Results Overview
The percent of participants with disease recurrence within 5 years
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
571 participants
Primary outcome timeframe
Up to 5 years
Results posted on
2019-06-04
Participant Flow
GOG 0175 accrued 571 patients from September 1998 to December 2006.
Participant milestones
| Measure |
Paclitaxel + Carboplatin Followed 4 Weeks Later by Paclitaxel
Paclitaxel 175 mg/m2 IV over 3 hours, Carboplatin AUC=6 IV every 21 days x 3 cycles Followed 4 weeks later by paclitaxel 40 mg/m2 over 1 hour every week for 24 weeks
|
Paclitaxel + Carboplatin Followed by Observation
Paclitaxel 175 mg/m2 IV over 3 hours, Carboplatin AUC=6 IV every 21 days x 3 cycles, followed by observation
|
|---|---|---|
|
Overall Study
STARTED
|
289
|
282
|
|
Overall Study
COMPLETED
|
274
|
268
|
|
Overall Study
NOT COMPLETED
|
15
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Carboplatin Plus Paclitaxel With or Without Continued Low-Dose Paclitaxel in Treating Patients With Early-Stage Ovarian Cancer
Baseline characteristics by cohort
| Measure |
Paclitaxel + Carboplatin Followed 4 Weeks Later by Paclitaxel
n=274 Participants
Paclitaxel 175 mg/m2 IV over 3 hours, Carboplatin AUC=6 IV every 21 days x 3 cycles Followed 4 weeks later by paclitaxel 40 mg/m2 over 1 hour every week for 24 weeks
|
Paclitaxel + Carboplatin Followed by Observation
n=268 Participants
Paclitaxel 175 mg/m2 IV over 3 hours, Carboplatin AUC=6 IV every 21 days x 3 cycles, followed by observation
|
Total
n=542 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Less than 40 years
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Age, Customized
40-49 years
|
66 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
88 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
186 Participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
64 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
|
Age, Customized
>=70 years
|
34 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
274 Participants
n=5 Participants
|
268 Participants
n=7 Participants
|
542 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 5 yearsPopulation: Eligible and treated participants
The percent of participants with disease recurrence within 5 years
Outcome measures
| Measure |
Paclitaxel + Carboplatin Followed 4 Weeks Later by Paclitaxel
n=274 Participants
Paclitaxel 175 mg/m2 IV over 3 hours, Carboplatin AUC=6 IV every 21 days x 3 cycles Followed 4 weeks later by paclitaxel 40 mg/m2 over 1 hour every week for 24 weeks
|
Paclitaxel + Carboplatin Followed by Observation
n=268 Participants
Paclitaxel 175 mg/m2 IV over 3 hours, Carboplatin AUC=6 IV every 21 days x 3 cycles, followed by observation
|
|---|---|---|
|
Progression-free Survival
|
20.4 percentage of participants
Interval 15.9 to 25.9
|
23.2 percentage of participants
Interval 18.4 to 28.9
|
PRIMARY outcome
Timeframe: up to 96 monthsPopulation: All eligible and treated participants
Number of deaths during study and follow up.
Outcome measures
| Measure |
Paclitaxel + Carboplatin Followed 4 Weeks Later by Paclitaxel
n=274 Participants
Paclitaxel 175 mg/m2 IV over 3 hours, Carboplatin AUC=6 IV every 21 days x 3 cycles Followed 4 weeks later by paclitaxel 40 mg/m2 over 1 hour every week for 24 weeks
|
Paclitaxel + Carboplatin Followed by Observation
n=268 Participants
Paclitaxel 175 mg/m2 IV over 3 hours, Carboplatin AUC=6 IV every 21 days x 3 cycles, followed by observation
|
|---|---|---|
|
Overall Survival
|
44 Participants
|
53 Participants
|
PRIMARY outcome
Timeframe: Throughout study treatment lasting up to 24 weeksPopulation: All treated participants
Toxicities, Grade 3 or greater (CTC version 2.0) by treatment arm for all treated participants
Outcome measures
| Measure |
Paclitaxel + Carboplatin Followed 4 Weeks Later by Paclitaxel
n=271 Participants
Paclitaxel 175 mg/m2 IV over 3 hours, Carboplatin AUC=6 IV every 21 days x 3 cycles Followed 4 weeks later by paclitaxel 40 mg/m2 over 1 hour every week for 24 weeks
|
Paclitaxel + Carboplatin Followed by Observation
n=265 Participants
Paclitaxel 175 mg/m2 IV over 3 hours, Carboplatin AUC=6 IV every 21 days x 3 cycles, followed by observation
|
|---|---|---|
|
Number of Participants With Adverse Events Grade 3 or Greater
Leukopenia
|
74 Participants
|
86 Participants
|
|
Number of Participants With Adverse Events Grade 3 or Greater
Thrombocytopenia
|
12 Participants
|
16 Participants
|
|
Number of Participants With Adverse Events Grade 3 or Greater
Neutropenia
|
203 Participants
|
196 Participants
|
|
Number of Participants With Adverse Events Grade 3 or Greater
Anemia
|
4 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events Grade 3 or Greater
Other hematologic
|
7 Participants
|
4 Participants
|
|
Number of Participants With Adverse Events Grade 3 or Greater
Allergy
|
8 Participants
|
7 Participants
|
|
Number of Participants With Adverse Events Grade 3 or Greater
Cardiovascular
|
12 Participants
|
7 Participants
|
|
Number of Participants With Adverse Events Grade 3 or Greater
Coagulation
|
0 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events Grade 3 or Greater
Constitutional
|
7 Participants
|
7 Participants
|
|
Number of Participants With Adverse Events Grade 3 or Greater
Dermatologic
|
2 Participants
|
3 Participants
|
|
Number of Participants With Adverse Events Grade 3 or Greater
Gastrointestinal
|
12 Participants
|
11 Participants
|
|
Number of Participants With Adverse Events Grade 3 or Greater
Genitourinary/Renal
|
1 Participants
|
3 Participants
|
|
Number of Participants With Adverse Events Grade 3 or Greater
Hemorrhage
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Grade 3 or Greater
Hepatic
|
1 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events Grade 3 or Greater
Infection/Fever
|
15 Participants
|
11 Participants
|
|
Number of Participants With Adverse Events Grade 3 or Greater
Metabolic
|
10 Participants
|
5 Participants
|
|
Number of Participants With Adverse Events Grade 3 or Greater
Musculoskeletal
|
3 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Grade 3 or Greater
Peripheral Neuropathy
|
12 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events Grade 3 or Greater
Other Neurologic
|
5 Participants
|
8 Participants
|
|
Number of Participants With Adverse Events Grade 3 or Greater
Ocular/Visual
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Grade 3 or Greater
Pain
|
15 Participants
|
12 Participants
|
|
Number of Participants With Adverse Events Grade 3 or Greater
Pulmonary
|
1 Participants
|
0 Participants
|
Adverse Events
Paclitaxel + Carboplatin Followed 4 Weeks Later by Paclitaxel
Serious events: 7 serious events
Other events: 271 other events
Deaths: 44 deaths
Paclitaxel + Carboplatin Followed by Observation
Serious events: 5 serious events
Other events: 265 other events
Deaths: 53 deaths
Serious adverse events
| Measure |
Paclitaxel + Carboplatin Followed 4 Weeks Later by Paclitaxel
n=274 participants at risk
Paclitaxel 175 mg/m2 IV over 3 hours, Carboplatin AUC=6 IV every 21 days x 3 cycles Followed 4 weeks later by paclitaxel 40 mg/m2 over 1 hour every week for 24 weeks
|
Paclitaxel + Carboplatin Followed by Observation
n=268 participants at risk
Paclitaxel 175 mg/m2 IV over 3 hours, Carboplatin AUC=6 IV every 21 days x 3 cycles, followed by observation
|
|---|---|---|
|
General disorders
Chest Pain
|
0.00%
0/274 • Up to 24 weeks
|
0.37%
1/268 • Number of events 1 • Up to 24 weeks
|
|
General disorders
Abdominal Pain
|
0.73%
2/274 • Number of events 3 • Up to 24 weeks
|
0.00%
0/268 • Up to 24 weeks
|
|
Infections and infestations
Urinary Tract Infection With E.Coli Bacteremia
|
0.36%
1/274 • Number of events 1 • Up to 24 weeks
|
0.00%
0/268 • Up to 24 weeks
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.36%
1/274 • Number of events 2 • Up to 24 weeks
|
0.00%
0/268 • Up to 24 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.36%
1/274 • Number of events 2 • Up to 24 weeks
|
0.37%
1/268 • Number of events 1 • Up to 24 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.36%
1/274 • Number of events 2 • Up to 24 weeks
|
0.37%
1/268 • Number of events 1 • Up to 24 weeks
|
|
Vascular disorders
Venous Thrombosis
|
0.36%
1/274 • Number of events 1 • Up to 24 weeks
|
0.00%
0/268 • Up to 24 weeks
|
|
Cardiac disorders
Cardiac Arrythmia
|
0.00%
0/274 • Up to 24 weeks
|
0.37%
1/268 • Number of events 1 • Up to 24 weeks
|
|
Gastrointestinal disorders
Ileus
|
0.36%
1/274 • Number of events 1 • Up to 24 weeks
|
0.00%
0/268 • Up to 24 weeks
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.36%
1/274 • Number of events 1 • Up to 24 weeks
|
0.00%
0/268 • Up to 24 weeks
|
|
Investigations
Fever with Neutropenia
|
0.00%
0/274 • Up to 24 weeks
|
0.37%
1/268 • Number of events 1 • Up to 24 weeks
|
|
Gastrointestinal disorders
Small Bowel Obstruction
|
0.36%
1/274 • Number of events 1 • Up to 24 weeks
|
0.00%
0/268 • Up to 24 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death due to Disease
|
0.00%
0/274 • Up to 24 weeks
|
0.37%
1/268 • Number of events 1 • Up to 24 weeks
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.36%
1/274 • Number of events 1 • Up to 24 weeks
|
0.00%
0/268 • Up to 24 weeks
|
Other adverse events
| Measure |
Paclitaxel + Carboplatin Followed 4 Weeks Later by Paclitaxel
n=274 participants at risk
Paclitaxel 175 mg/m2 IV over 3 hours, Carboplatin AUC=6 IV every 21 days x 3 cycles Followed 4 weeks later by paclitaxel 40 mg/m2 over 1 hour every week for 24 weeks
|
Paclitaxel + Carboplatin Followed by Observation
n=268 participants at risk
Paclitaxel 175 mg/m2 IV over 3 hours, Carboplatin AUC=6 IV every 21 days x 3 cycles, followed by observation
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
90.1%
247/274 • Number of events 247 • Up to 24 weeks
|
88.1%
236/268 • Number of events 236 • Up to 24 weeks
|
|
Blood and lymphatic system disorders
Anema
|
79.9%
219/274 • Number of events 219 • Up to 24 weeks
|
78.0%
209/268 • Number of events 209 • Up to 24 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
44.5%
122/274 • Number of events 122 • Up to 24 weeks
|
40.7%
109/268 • Number of events 109 • Up to 24 weeks
|
|
Blood and lymphatic system disorders
Neutropenia
|
93.1%
255/274 • Number of events 255 • Up to 24 weeks
|
92.2%
247/268 • Number of events 247 • Up to 24 weeks
|
|
Blood and lymphatic system disorders
Other Hematologic
|
4.7%
13/274 • Number of events 13 • Up to 24 weeks
|
4.9%
13/268 • Number of events 13 • Up to 24 weeks
|
|
Immune system disorders
Allergy
|
14.2%
39/274 • Number of events 39 • Up to 24 weeks
|
9.0%
24/268 • Number of events 24 • Up to 24 weeks
|
|
Ear and labyrinth disorders
Auditory
|
6.2%
17/274 • Number of events 17 • Up to 24 weeks
|
2.6%
7/268 • Number of events 7 • Up to 24 weeks
|
|
Cardiac disorders
Cardiovascular
|
19.0%
52/274 • Number of events 52 • Up to 24 weeks
|
8.2%
22/268 • Number of events 22 • Up to 24 weeks
|
|
Vascular disorders
Coagulation
|
1.1%
3/274 • Number of events 3 • Up to 24 weeks
|
1.5%
4/268 • Number of events 4 • Up to 24 weeks
|
|
General disorders
Constitutional
|
66.4%
182/274 • Number of events 182 • Up to 24 weeks
|
59.3%
159/268 • Number of events 159 • Up to 24 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatologic
|
78.5%
215/274 • Number of events 215 • Up to 24 weeks
|
68.3%
183/268 • Number of events 183 • Up to 24 weeks
|
|
Endocrine disorders
Endocrine
|
11.7%
32/274 • Number of events 32 • Up to 24 weeks
|
7.1%
19/268 • Number of events 19 • Up to 24 weeks
|
|
Gastrointestinal disorders
Gastrointestinal
|
70.4%
193/274 • Number of events 193 • Up to 24 weeks
|
67.2%
180/268 • Number of events 180 • Up to 24 weeks
|
|
Vascular disorders
Hemorrhage
|
6.6%
18/274 • Number of events 18 • Up to 24 weeks
|
4.1%
11/268 • Number of events 11 • Up to 24 weeks
|
|
Hepatobiliary disorders
Hepatic
|
9.9%
27/274 • Number of events 27 • Up to 24 weeks
|
8.2%
22/268 • Number of events 22 • Up to 24 weeks
|
|
Infections and infestations
Infection/Fever
|
22.3%
61/274 • Number of events 61 • Up to 24 weeks
|
9.3%
25/268 • Number of events 25 • Up to 24 weeks
|
|
Blood and lymphatic system disorders
Lymphatics
|
4.4%
12/274 • Number of events 12 • Up to 24 weeks
|
1.1%
3/268 • Number of events 3 • Up to 24 weeks
|
|
Metabolism and nutrition disorders
Metabolic
|
19.3%
53/274 • Number of events 53 • Up to 24 weeks
|
12.7%
34/268 • Number of events 34 • Up to 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
11.3%
31/274 • Number of events 31 • Up to 24 weeks
|
8.6%
23/268 • Number of events 23 • Up to 24 weeks
|
|
Nervous system disorders
Neurologic
|
26.6%
73/274 • Number of events 73 • Up to 24 weeks
|
18.7%
50/268 • Number of events 50 • Up to 24 weeks
|
|
Nervous system disorders
Peripheral neurologic
|
56.9%
156/274 • Number of events 156 • Up to 24 weeks
|
40.3%
108/268 • Number of events 108 • Up to 24 weeks
|
|
Eye disorders
Ocular Visual
|
9.9%
27/274 • Number of events 27 • Up to 24 weeks
|
7.8%
21/268 • Number of events 21 • Up to 24 weeks
|
|
General disorders
Pain
|
59.9%
164/274 • Number of events 164 • Up to 24 weeks
|
56.0%
150/268 • Number of events 150 • Up to 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
15.0%
41/274 • Number of events 41 • Up to 24 weeks
|
7.5%
20/268 • Number of events 20 • Up to 24 weeks
|
|
Reproductive system and breast disorders
Sexual
|
4.7%
13/274 • Number of events 13 • Up to 24 weeks
|
4.1%
11/268 • Number of events 11 • Up to 24 weeks
|
Additional Information
Linda Gedeon, Christopher Purdy on behalf of Mark Brady, PhD
NRG Oncology
Phone: (716) 845-1169
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60