Trial Outcomes & Findings for Chemoimmunotherapy Study for Patients With Epithelial Ovarian Cancer (NCT NCT00501644)

Last Updated: 2012-08-07

Results Overview

Per World Health Organization (WHO) Tumor Response: Complete Response (CR), Partial Response (PR) or Progressive Disease (PD). CR defined as disappearance of all target lesions, PR as \> = 30% decrease in sum of longest dimensions of target lesions with reference baseline sum longest dimensions and if CA 125 levels declined by \>50%, provided target lesion size did not increase by \>20% on imaging, and PD as \>20% increase in sum of longest dimensions of target lesions taking as references smallest sum of longest dimensions recorded since treatment started, or appearance of 1 or \> new lesions.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

59 participants

Primary outcome timeframe

Follow up CT scans after every 3 courses of treatment and following completion of all treatments.

Results posted on

2012-08-07

Participant Flow

Recruitment period 01/07/03 to 07/25/07. All patients were recruited at UT MD Anderson Cancer Center.

Participant milestones

Participant milestones
Measure	Chemoimmunotherapy GM-CSF Starting dose of 400 mg injected under the skin once a day for 7 days prior to and following each course of chemotherapy + rIFN-g (Interferon Gamma) 0.1 mg injected under the skin for 2 days before and after chemotherapy (Day 5 and Day 7 of each 7-day GM-CSF cycle) + Paraplatin (Carboplatin) AUC of 5 by 1 hour IV infusion every 28 days
Overall Study STARTED	59
Overall Study COMPLETED	54
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Chemoimmunotherapy GM-CSF Starting dose of 400 mg injected under the skin once a day for 7 days prior to and following each course of chemotherapy + rIFN-g (Interferon Gamma) 0.1 mg injected under the skin for 2 days before and after chemotherapy (Day 5 and Day 7 of each 7-day GM-CSF cycle) + Paraplatin (Carboplatin) AUC of 5 by 1 hour IV infusion every 28 days
Overall Study Adverse Event	4
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Chemoimmunotherapy Study for Patients With Epithelial Ovarian Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chemoimmunotherapy n=59 Participants GM-CSF Starting dose of 400 mg injected under the skin once a day for 7 days prior to and following each course of chemotherapy + rIFN-g (Interferon Gamma) 0.1 mg injected under the skin for 2 days before and after chemotherapy (Day 5 and Day 7 of each 7-day GM-CSF cycle) + Paraplatin (Carboplatin) AUC of 5 by 1 hour IV infusion every 28 days
Age Continuous	61 years n=5 Participants
Sex/Gender, Customized Female	59 participants n=5 Participants
Sex/Gender, Customized Male	0 participants n=5 Participants
Region of Enrollment United States	59 participants n=5 Participants

PRIMARY outcome

Timeframe: Follow up CT scans after every 3 courses of treatment and following completion of all treatments.

Population: Analysis per protocol. Of 59 participants enrolled, five (5) were not evaluable.

Outcome measures

Outcome measures
Measure	Chemoimmunotherapy n=54 Participants GM-CSF Starting dose of 400 mg injected under the skin once a day for 7 days prior to and following each course of chemotherapy + rIFN-g (Interferon Gamma) 0.1 mg injected under the skin for 2 days before and after chemotherapy (Day 5 and Day 7 of each 7-day GM-CSF cycle) + Paraplatin (Carboplatin) AUC of 5 by 1 hour IV infusion every 28 days
Number of Patients With Response Complete Response	9 Participants
Number of Patients With Response Partial Response	21 Participants
Number of Patients With Response Progressive Disease	24 Participants

Adverse Events

Chemoimmunotherapy

Serious events: 20 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Chemoimmunotherapy n=54 participants at risk GM-CSF Starting dose of 400 mg injected under the skin once a day for 7 days prior to and following each course of chemotherapy + rIFN-g (Interferon Gamma) 0.1 mg injected under the skin for 2 days before and after chemotherapy (Day 5 and Day 7 of each 7-day GM-CSF cycle) + Paraplatin (Carboplatin) AUC of 5 by 1 hour IV infusion every 28 days
Investigations Neutrophil count decreased	29.6% 16/54 • Number of events 16 • Five years and three months
Investigations Platelet count decreased	16.7% 9/54 • Number of events 9 • Five years and three months
Blood and lymphatic system disorders Anemia	3.7% 2/54 • Number of events 2 • Five years and three months
General disorders Fatigue	37.0% 20/54 • Number of events 20 • Five years and three months
General disorders Infusion related reaction	27.8% 15/54 • Number of events 15 • Five years and three months
Musculoskeletal and connective tissue disorders Myalgia	18.5% 10/54 • Number of events 10 • Five years and three months
Psychiatric disorders Depression/Anxiety	14.8% 8/54 • Number of events 8 • Five years and three months
Gastrointestinal disorders Nausea	9.3% 5/54 • Number of events 5 • Five years and three months
Nervous system disorders Headache	3.7% 2/54 • Number of events 2 • Five years and three months
Nervous system disorders Peripheral Sensory Neuropathy	5.6% 3/54 • Number of events 3 • Five years and three months
Investigations Elevated Liver Enzymes	3.7% 2/54 • Number of events 2 • Five years and three months

Other adverse events

Adverse event data not reported

Additional Information

Michael E. Garcia, RN, BSN

UT MD Anderson Cancer Center

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place