Trial Outcomes & Findings for Carboplatin, Paclitaxel, and Surgery in Treating Patients With Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer (NCT NCT00331422)
NCT ID: NCT00331422
Last Updated: 2017-12-28
Results Overview
These patients had their tumor(s) removed by surgery after receiving 4 cycles of chemotherapy to determine their response.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
7 participants
Primary outcome timeframe
Week 18 (After 4 cycles of chemotherapy)
Results posted on
2017-12-28
Participant Flow
Participant milestones
| Measure |
Patients Who Received Treatment
Includes all patients enrolled and treated with at least one dose of chemotherapy (carboplatin - dose calculated per Calvert formula - given intravenously for 30 minutes and/or paclitaxel 175 milligrams per meter squared over 3 hours).
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Patients Who Received Treatment
Includes all patients enrolled and treated with at least one dose of chemotherapy (carboplatin - dose calculated per Calvert formula - given intravenously for 30 minutes and/or paclitaxel 175 milligrams per meter squared over 3 hours).
|
|---|---|
|
Overall Study
Did not receive entire study regimen
|
5
|
Baseline Characteristics
Carboplatin, Paclitaxel, and Surgery in Treating Patients With Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer
Baseline characteristics by cohort
| Measure |
Patients Who Received Treatment
n=7 Participants
Includes all patients enrolled and treated with at least one dose of chemotherapy (carboplatin - dose calculated per Calvert formula - given intravenously for 30 minutes and/or paclitaxel 175 milligrams per meter squared over 3 hours).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
67 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 18 (After 4 cycles of chemotherapy)Population: Includes those patients that received 4 cycles of therapy before removal of cancerous tissue. Evaluation of overall response is not possible due to low number of patients and therefore could not obtain statistical significance.
These patients had their tumor(s) removed by surgery after receiving 4 cycles of chemotherapy to determine their response.
Outcome measures
| Measure |
Evaluable Patients (Received 4 Cycles of Therapy and Surgery)
n=2 Participants
Includes patients treated with 4 cycles of study chemotherapy regimen and surgery.
|
|---|---|
|
Number of Patients Who Underwent Optimal Cytoreduction After Chemotherapy
|
2 Participants
|
SECONDARY outcome
Timeframe: Week 16 (4 weeks after 4th course)Best response recorded from start of treatment until after 4th cycle of treatment. Defined by the sum of Complete Responses (CR), Partial Responses (PR), and Stable Disease (SD) in patients neoadjuvant chemotherapy. CR=disappearance of all lesions, PR=\>or=30% decrease in sumof all target lesins, Progressive Disease (PD) =\>or =20% increase in sum of all target or any new lesions, SD=not CR, PR or PD.
Outcome measures
| Measure |
Evaluable Patients (Received 4 Cycles of Therapy and Surgery)
n=7 Participants
Includes patients treated with 4 cycles of study chemotherapy regimen and surgery.
|
|---|---|
|
Patients' Overall Tumor Response as Measured by Response Evaluation Criteria in Solid Tumors (RECIST)
Partial Response
|
2 Participants
|
|
Patients' Overall Tumor Response as Measured by Response Evaluation Criteria in Solid Tumors (RECIST)
Progressive Disease
|
3 Participants
|
|
Patients' Overall Tumor Response as Measured by Response Evaluation Criteria in Solid Tumors (RECIST)
Stable Disease
|
2 Participants
|
SECONDARY outcome
Timeframe: From Baseline to up to 12 weeks (4 courses of therapy)Ca-125 serum results compared from baseline to after patient's last treatment. This is a tumor biomarker. A decrease in results indicates a clinical response.
Outcome measures
| Measure |
Evaluable Patients (Received 4 Cycles of Therapy and Surgery)
n=7 Participants
Includes patients treated with 4 cycles of study chemotherapy regimen and surgery.
|
|---|---|
|
Clinical Response Based on Serum Cancer Antigen 125 (CA-125) Concentration
Increased Concentration
|
1 Participants
|
|
Clinical Response Based on Serum Cancer Antigen 125 (CA-125) Concentration
Decreased Concentration
|
6 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Time to Surgery (Approximately Week 18)As measured by extreme drug resistance assay - Unable to report due to tissue samples being incomplete or unsatisfactory to do laboratory testing.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 18 (At surgery)Unable to report due to incomplete (nonviable) or unsatisfactory tissue samples.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1, Week 12 (after 4th course) , Week 16 (4 weeks after last treatment)Functional Assessment of Cancer Therapy-Ovarian (FACT-O) Questionnaire was used to assess the impact of treatment- and disease-related factors on the quality of life of patients with ovarian cancers undergoing chemotherapy. It is a 5 point scale (from worse to best: 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much responses). Physical well-being, social/family well-being, functional well-being, emotional well-being and additional concerns questions are asked. Unable to evaluate; patients did not consistently complete the questionnaires.
Outcome measures
Outcome data not reported
Adverse Events
Patients Who Received Treatment
Serious events: 6 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Patients Who Received Treatment
n=7 participants at risk
Includes all patients enrolled and treated with at least one dose of chemotherapy (carboplatin - dose calculated per Calvert formula - given intravenously for 30 minutes and/or paclitaxel 175 milligrams per meter squared over 3 hours).
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from Day 1 of treatment through 30 days post treatment or death, whichever came first.
All events are reported; related and unrelated to study treatment.
|
|
Nervous system disorders
Anxiety
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from Day 1 of treatment through 30 days post treatment or death, whichever came first.
All events are reported; related and unrelated to study treatment.
|
|
Gastrointestinal disorders
Bowel obstruction
|
42.9%
3/7 • Number of events 3 • Adverse events were collected from Day 1 of treatment through 30 days post treatment or death, whichever came first.
All events are reported; related and unrelated to study treatment.
|
|
Nervous system disorders
Confusion
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from Day 1 of treatment through 30 days post treatment or death, whichever came first.
All events are reported; related and unrelated to study treatment.
|
|
Gastrointestinal disorders
Dehydration
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from Day 1 of treatment through 30 days post treatment or death, whichever came first.
All events are reported; related and unrelated to study treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from Day 1 of treatment through 30 days post treatment or death, whichever came first.
All events are reported; related and unrelated to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from Day 1 of treatment through 30 days post treatment or death, whichever came first.
All events are reported; related and unrelated to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from Day 1 of treatment through 30 days post treatment or death, whichever came first.
All events are reported; related and unrelated to study treatment.
|
|
Gastrointestinal disorders
Fistula, gastrointestinal
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from Day 1 of treatment through 30 days post treatment or death, whichever came first.
All events are reported; related and unrelated to study treatment.
|
|
Gastrointestinal disorders
Hemorrhage
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from Day 1 of treatment through 30 days post treatment or death, whichever came first.
All events are reported; related and unrelated to study treatment.
|
|
Renal and urinary disorders
Hydronephrosis
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from Day 1 of treatment through 30 days post treatment or death, whichever came first.
All events are reported; related and unrelated to study treatment.
|
|
Infections and infestations
Infection
|
28.6%
2/7 • Number of events 4 • Adverse events were collected from Day 1 of treatment through 30 days post treatment or death, whichever came first.
All events are reported; related and unrelated to study treatment.
|
|
Renal and urinary disorders
Infection, bladder
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from Day 1 of treatment through 30 days post treatment or death, whichever came first.
All events are reported; related and unrelated to study treatment.
|
|
Cardiac disorders
Myocardial infarction
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from Day 1 of treatment through 30 days post treatment or death, whichever came first.
All events are reported; related and unrelated to study treatment.
|
|
Gastrointestinal disorders
Nausea
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from Day 1 of treatment through 30 days post treatment or death, whichever came first.
All events are reported; related and unrelated to study treatment.
|
|
Nervous system disorders
Neuropathy
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from Day 1 of treatment through 30 days post treatment or death, whichever came first.
All events are reported; related and unrelated to study treatment.
|
|
General disorders
Other, Failure to Thrive
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from Day 1 of treatment through 30 days post treatment or death, whichever came first.
All events are reported; related and unrelated to study treatment.
|
|
General disorders
Pain
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from Day 1 of treatment through 30 days post treatment or death, whichever came first.
All events are reported; related and unrelated to study treatment.
|
|
Vascular disorders
Pulmonary embolism
|
28.6%
2/7 • Number of events 2 • Adverse events were collected from Day 1 of treatment through 30 days post treatment or death, whichever came first.
All events are reported; related and unrelated to study treatment.
|
|
Renal and urinary disorders
Renal insufficiency
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from Day 1 of treatment through 30 days post treatment or death, whichever came first.
All events are reported; related and unrelated to study treatment.
|
|
Skin and subcutaneous tissue disorders
Wound complication
|
42.9%
3/7 • Number of events 3 • Adverse events were collected from Day 1 of treatment through 30 days post treatment or death, whichever came first.
All events are reported; related and unrelated to study treatment.
|
Other adverse events
| Measure |
Patients Who Received Treatment
n=7 participants at risk
Includes all patients enrolled and treated with at least one dose of chemotherapy (carboplatin - dose calculated per Calvert formula - given intravenously for 30 minutes and/or paclitaxel 175 milligrams per meter squared over 3 hours).
|
|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
100.0%
7/7 • Number of events 7 • Adverse events were collected from Day 1 of treatment through 30 days post treatment or death, whichever came first.
All events are reported; related and unrelated to study treatment.
|
|
Blood and lymphatic system disorders
Anemia
|
28.6%
2/7 • Number of events 2 • Adverse events were collected from Day 1 of treatment through 30 days post treatment or death, whichever came first.
All events are reported; related and unrelated to study treatment.
|
|
Nervous system disorders
Anxiety
|
28.6%
2/7 • Number of events 2 • Adverse events were collected from Day 1 of treatment through 30 days post treatment or death, whichever came first.
All events are reported; related and unrelated to study treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from Day 1 of treatment through 30 days post treatment or death, whichever came first.
All events are reported; related and unrelated to study treatment.
|
|
Eye disorders
Double Vision
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from Day 1 of treatment through 30 days post treatment or death, whichever came first.
All events are reported; related and unrelated to study treatment.
|
|
General disorders
Fatigue
|
28.6%
2/7 • Number of events 2 • Adverse events were collected from Day 1 of treatment through 30 days post treatment or death, whichever came first.
All events are reported; related and unrelated to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Hip Pain
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from Day 1 of treatment through 30 days post treatment or death, whichever came first.
All events are reported; related and unrelated to study treatment.
|
|
General disorders
Infection
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from Day 1 of treatment through 30 days post treatment or death, whichever came first.
All events are reported; related and unrelated to study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
57.1%
4/7 • Number of events 4 • Adverse events were collected from Day 1 of treatment through 30 days post treatment or death, whichever came first.
All events are reported; related and unrelated to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oxygen, decreased (pulmonary-atelectasis)
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from Day 1 of treatment through 30 days post treatment or death, whichever came first.
All events are reported; related and unrelated to study treatment.
|
|
General disorders
Pain
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from Day 1 of treatment through 30 days post treatment or death, whichever came first.
All events are reported; related and unrelated to study treatment.
|
|
Blood and lymphatic system disorders
Peripheral Edema (limb)
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from Day 1 of treatment through 30 days post treatment or death, whichever came first.
All events are reported; related and unrelated to study treatment.
|
|
Nervous system disorders
Sleep Apnea
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from Day 1 of treatment through 30 days post treatment or death, whichever came first.
All events are reported; related and unrelated to study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
42.9%
3/7 • Number of events 3 • Adverse events were collected from Day 1 of treatment through 30 days post treatment or death, whichever came first.
All events are reported; related and unrelated to study treatment.
|
|
Ear and labyrinth disorders
Tinnitus (ringing in ears)
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from Day 1 of treatment through 30 days post treatment or death, whichever came first.
All events are reported; related and unrelated to study treatment.
|
Additional Information
Melissa Geller, MD
Masonic Cancer Center, University of Minnesota
Phone: 612-626-3111
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place