Trial Outcomes & Findings for Sargramostim and Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer That Did Not Respond to Previous Chemotherapy (NCT NCT00466960)
NCT ID: NCT00466960
Last Updated: 2017-08-28
Results Overview
Median time to progression
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
21 participants
Primary outcome timeframe
Up to 5 years
Results posted on
2017-08-28
Participant Flow
Participant milestones
| Measure |
Treatment (Colony Stimulating Factor and Chemotherapy)
INDUCTION THERAPY: Patients receive Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) subcutaneously (SC) once daily on days 16-26. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Beginning 14 days after last GM-CSF injection, patients receive GM-CSF SC once daily on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
sargramostim: Given SC
paclitaxel albumin-stabilized nanoparticle formulation: Given IV
laboratory biomarker analysis: Correlative studies
immunologic technique: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
21
|
|
Overall Study
COMPLETED
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sargramostim and Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer That Did Not Respond to Previous Chemotherapy
Baseline characteristics by cohort
| Measure |
Treatment (Colony Stimulating Factor and Chemotherapy)
n=21 Participants
INDUCTION THERAPY: Patients receive GM-CSF SC once daily on days 16-26. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Beginning 14 days after last GM-CSF injection, patients receive GM-CSF SC once daily on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
sargramostim: Given SC
paclitaxel albumin-stabilized nanoparticle formulation: Given IV
laboratory biomarker analysis: Correlative studies
immunologic technique: Correlative studies
|
|---|---|
|
Age, Continuous
|
61 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 5 yearsMedian time to progression
Outcome measures
| Measure |
Treatment (Colony Stimulating Factor and Chemotherapy)
n=21 Participants
INDUCTION THERAPY: Patients receive GM-CSF SC once daily on days 16-26. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Beginning 14 days after last GM-CSF injection, patients receive GM-CSF SC once daily on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
sargramostim: Given SC
paclitaxel albumin-stabilized nanoparticle formulation: Given IV
laboratory biomarker analysis: Correlative studies
immunologic technique: Correlative studies
|
|---|---|
|
Time to Progression
|
4.07 months
Interval 2.74 to 6.71
|
PRIMARY outcome
Timeframe: Up to 5 yearsNumber of patients achieving a complete or partial response.
Outcome measures
| Measure |
Treatment (Colony Stimulating Factor and Chemotherapy)
n=21 Participants
INDUCTION THERAPY: Patients receive GM-CSF SC once daily on days 16-26. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Beginning 14 days after last GM-CSF injection, patients receive GM-CSF SC once daily on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
sargramostim: Given SC
paclitaxel albumin-stabilized nanoparticle formulation: Given IV
laboratory biomarker analysis: Correlative studies
immunologic technique: Correlative studies
|
|---|---|
|
Response Rate
|
15 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsBaseline median percentages of CD45+ cells made up of monocytes in complete responders (CR) compared to partial-responders, non-responders and those with stable disease (PR+NR+SD).
Outcome measures
| Measure |
Treatment (Colony Stimulating Factor and Chemotherapy)
n=21 Participants
INDUCTION THERAPY: Patients receive GM-CSF SC once daily on days 16-26. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Beginning 14 days after last GM-CSF injection, patients receive GM-CSF SC once daily on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
sargramostim: Given SC
paclitaxel albumin-stabilized nanoparticle formulation: Given IV
laboratory biomarker analysis: Correlative studies
immunologic technique: Correlative studies
|
|---|---|
|
Correlation Between Circulating Monocytes and Time to Progression
CR
|
20.75 percentage of CD45+ in PBSC
Interval 10.98 to 24.93
|
|
Correlation Between Circulating Monocytes and Time to Progression
PR+NR+SD
|
12.75 percentage of CD45+ in PBSC
Interval 11.24 to 30.1
|
SECONDARY outcome
Timeframe: Up to 5 yearsBaseline median percentages of CD45+ cells made up of myeloid dendritic cells (mDC) and plasmacytoid dendritic cells (pDC) in complete responders (CR) compared to partial and non-responders (PR+NR+SD).
Outcome measures
| Measure |
Treatment (Colony Stimulating Factor and Chemotherapy)
n=21 Participants
INDUCTION THERAPY: Patients receive GM-CSF SC once daily on days 16-26. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Beginning 14 days after last GM-CSF injection, patients receive GM-CSF SC once daily on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
sargramostim: Given SC
paclitaxel albumin-stabilized nanoparticle formulation: Given IV
laboratory biomarker analysis: Correlative studies
immunologic technique: Correlative studies
|
|---|---|
|
Correlation Between Circulating Dendritic Cell Count and Maturation State With Clinical Response and Response Duration
pDC in CR
|
0.2465 % of CD45+PBMC
Interval 0.1924 to 0.3362
|
|
Correlation Between Circulating Dendritic Cell Count and Maturation State With Clinical Response and Response Duration
pDC in PR+NR+SD
|
0.3743 % of CD45+PBMC
Interval 0.2311 to 0.5067
|
|
Correlation Between Circulating Dendritic Cell Count and Maturation State With Clinical Response and Response Duration
mDC in CR
|
1.543 % of CD45+PBMC
Interval 1.075 to 3.504
|
|
Correlation Between Circulating Dendritic Cell Count and Maturation State With Clinical Response and Response Duration
mDC in PR+NR+SD
|
1.996 % of CD45+PBMC
Interval 1.232 to 2.42
|
SECONDARY outcome
Timeframe: Up to 5 yearsCorrelation of time to progression and change in circulating activated T lymphocytes from baseline to follow-up.
Outcome measures
| Measure |
Treatment (Colony Stimulating Factor and Chemotherapy)
n=21 Participants
INDUCTION THERAPY: Patients receive GM-CSF SC once daily on days 16-26. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Beginning 14 days after last GM-CSF injection, patients receive GM-CSF SC once daily on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
sargramostim: Given SC
paclitaxel albumin-stabilized nanoparticle formulation: Given IV
laboratory biomarker analysis: Correlative studies
immunologic technique: Correlative studies
|
|---|---|
|
Precursor Frequency of Circulating Activated T Lymphocytes Against Common Ovarian Cancer Tumor Associated Antigens to Measure the Development of Immunity to Anti-tumor Antigens
IGF1R-p1196-1210
|
0.5056 Pearson correlation
Interval -0.03429 to 0.8171
|
|
Precursor Frequency of Circulating Activated T Lymphocytes Against Common Ovarian Cancer Tumor Associated Antigens to Measure the Development of Immunity to Anti-tumor Antigens
IGF1R-p1242-1256
|
0.8496 Pearson correlation
Interval 0.5807 to 0.9513
|
|
Precursor Frequency of Circulating Activated T Lymphocytes Against Common Ovarian Cancer Tumor Associated Antigens to Measure the Development of Immunity to Anti-tumor Antigens
IGF1R-p1332-1346
|
0.8269 Pearson correlation
Interval 0.5279 to 0.9435
|
|
Precursor Frequency of Circulating Activated T Lymphocytes Against Common Ovarian Cancer Tumor Associated Antigens to Measure the Development of Immunity to Anti-tumor Antigens
IGFBP2
|
0.3676 Pearson correlation
Interval -0.2982 to 0.7927
|
|
Precursor Frequency of Circulating Activated T Lymphocytes Against Common Ovarian Cancer Tumor Associated Antigens to Measure the Development of Immunity to Anti-tumor Antigens
p53
|
-0.02268 Pearson correlation
Interval -0.5667 to 0.5351
|
|
Precursor Frequency of Circulating Activated T Lymphocytes Against Common Ovarian Cancer Tumor Associated Antigens to Measure the Development of Immunity to Anti-tumor Antigens
PRAME
|
-0.0817 Pearson correlation
Interval -0.5869 to 0.4693
|
SECONDARY outcome
Timeframe: Up to 5 yearsCorrelation of time to progression and change in circulating activated T lymphocytes from baseline to follow-up.
Outcome measures
| Measure |
Treatment (Colony Stimulating Factor and Chemotherapy)
n=21 Participants
INDUCTION THERAPY: Patients receive GM-CSF SC once daily on days 16-26. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Beginning 14 days after last GM-CSF injection, patients receive GM-CSF SC once daily on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
sargramostim: Given SC
paclitaxel albumin-stabilized nanoparticle formulation: Given IV
laboratory biomarker analysis: Correlative studies
immunologic technique: Correlative studies
|
|---|---|
|
Precursor Frequency of Circulating T Lymphocytes Activated Against Foreign Antigens
PHA
|
-0.08759 Pearson correlation
Interval -0.5908 to 0.4647
|
|
Precursor Frequency of Circulating T Lymphocytes Activated Against Foreign Antigens
CEF
|
-0.1818 Pearson correlation
Interval -0.6498 to 0.3862
|
|
Precursor Frequency of Circulating T Lymphocytes Activated Against Foreign Antigens
tetanus toxoid
|
-0.1071 Pearson correlation
Interval -0.6035 to 0.4491
|
Adverse Events
Treatment (Colony Stimulating Factor and Chemotherapy)
Serious events: 2 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Colony Stimulating Factor and Chemotherapy)
n=21 participants at risk
INDUCTION THERAPY: Patients receive GM-CSF SC once daily on days 16-26. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Beginning 14 days after last GM-CSF injection, patients receive GM-CSF SC once daily on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
sargramostim: Given SC
paclitaxel albumin-stabilized nanoparticle formulation: Given IV
laboratory biomarker analysis: Correlative studies
immunologic technique: Correlative studies
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
9.5%
2/21 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
9.5%
2/21 • Number of events 2
|
|
Gastrointestinal disorders
Obstruction, GI
|
4.8%
1/21 • Number of events 1
|
|
General disorders
Abdomen NOS
|
4.8%
1/21 • Number of events 1
|
Other adverse events
| Measure |
Treatment (Colony Stimulating Factor and Chemotherapy)
n=21 participants at risk
INDUCTION THERAPY: Patients receive GM-CSF SC once daily on days 16-26. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Beginning 14 days after last GM-CSF injection, patients receive GM-CSF SC once daily on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
sargramostim: Given SC
paclitaxel albumin-stabilized nanoparticle formulation: Given IV
laboratory biomarker analysis: Correlative studies
immunologic technique: Correlative studies
|
|---|---|
|
Immune system disorders
Allergic Reaction/Hypersensitivity (Including drug fever)
|
9.5%
2/21
|
|
Ear and labyrinth disorders
Tinnitus
|
9.5%
2/21
|
|
Blood and lymphatic system disorders
Low HCT
|
9.5%
2/21
|
|
Blood and lymphatic system disorders
Hematocrit
|
14.3%
3/21
|
|
Blood and lymphatic system disorders
RBC
|
9.5%
2/21
|
|
Blood and lymphatic system disorders
Hemoglobin
|
61.9%
13/21
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
52.4%
11/21
|
|
Blood and lymphatic system disorders
Lymphopenia
|
28.6%
6/21
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
28.6%
6/21
|
|
Blood and lymphatic system disorders
Platelets
|
9.5%
2/21
|
|
Cardiac disorders
Hypertension
|
9.5%
2/21
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
42.9%
9/21
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
9.5%
2/21
|
|
General disorders
Rigors/Chills
|
9.5%
2/21
|
|
General disorders
Weight Gain
|
9.5%
2/21
|
|
General disorders
Weight Loss
|
9.5%
2/21
|
|
General disorders
Death not associated with CTCAE term
|
19.0%
4/21
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
14.3%
3/21
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
33.3%
7/21
|
|
Skin and subcutaneous tissue disorders
Injection site reaction/extravasation changes
|
28.6%
6/21
|
|
Skin and subcutaneous tissue disorders
Nail Changes
|
14.3%
3/21
|
|
Skin and subcutaneous tissue disorders
Rash: Acne/Acneiform
|
9.5%
2/21
|
|
Gastrointestinal disorders
Anorexia
|
23.8%
5/21
|
|
Gastrointestinal disorders
Constipation
|
14.3%
3/21
|
|
Gastrointestinal disorders
Diarrhea
|
19.0%
4/21
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic)
|
9.5%
2/21
|
|
Gastrointestinal disorders
Nausea
|
28.6%
6/21
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
7/21
|
|
Blood and lymphatic system disorders
Edema:limb
|
23.8%
5/21
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
33.3%
7/21
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
9.5%
2/21
|
|
Metabolism and nutrition disorders
GFR
|
9.5%
2/21
|
|
Metabolism and nutrition disorders
Low Protein
|
9.5%
2/21
|
|
Metabolism and nutrition disorders
Hypokalemia
|
23.8%
5/21
|
|
Metabolism and nutrition disorders
Hyponatremia
|
23.8%
5/21
|
|
General disorders
Memory Impairment
|
9.5%
2/21
|
|
General disorders
Somnolence/depressed level of consciousness
|
9.5%
2/21
|
|
General disorders
Arthralgia (Pain)
|
9.5%
2/21
|
|
General disorders
Bone Pain
|
19.0%
4/21
|
|
General disorders
Head pain/Headache
|
19.0%
4/21
|
|
General disorders
Joint Pain
|
9.5%
2/21
|
|
General disorders
Muscle Pain
|
14.3%
3/21
|
|
General disorders
Myalgia (Pain)
|
9.5%
2/21
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
14.3%
3/21
|
|
Renal and urinary disorders
Urinary Retention (including neurogenic bladder)
|
9.5%
2/21
|
|
General disorders
Flu-like syndrome
|
19.0%
4/21
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place