Paclitaxel, Polyglutamate Paclitaxel, or Observation in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Peritoneal Cancer, or Fallopian Tube Cancer
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ClinicalTrials.gov Identifier: NCT00108745 |
Recruitment Status :
Active, not recruiting
First Posted : April 19, 2005
Results First Posted : April 1, 2021
Last Update Posted : September 30, 2021
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Conditions |
Fallopian Tube Clear Cell Adenocarcinoma Fallopian Tube Endometrioid Adenocarcinoma Fallopian Tube Mucinous Adenocarcinoma Fallopian Tube Serous Adenocarcinoma Fallopian Tube Transitional Cell Carcinoma Fallopian Tube Undifferentiated Carcinoma Ovarian Brenner Tumor Ovarian Clear Cell Adenocarcinoma Ovarian Endometrioid Adenocarcinoma Ovarian Mucinous Adenocarcinoma Ovarian Seromucinous Carcinoma Ovarian Serous Adenocarcinoma Ovarian Transitional Cell Carcinoma Ovarian Undifferentiated Carcinoma Primary Peritoneal Serous Adenocarcinoma Stage IIIA Fallopian Tube Cancer AJCC v7 Stage IIIA Ovarian Cancer AJCC v6 and v7 Stage IIIA Primary Peritoneal Cancer AJCC v7 Stage IIIB Fallopian Tube Cancer AJCC v7 Stage IIIB Ovarian Cancer AJCC v6 and v7 Stage IIIB Primary Peritoneal Cancer AJCC v7 Stage IIIC Fallopian Tube Cancer AJCC v7 Stage IIIC Ovarian Cancer AJCC v6 and v7 Stage IIIC Primary Peritoneal Cancer AJCC v7 Stage IV Fallopian Tube Cancer AJCC v6 and v7 Stage IV Ovarian Cancer AJCC v6 and v7 Stage IV Primary Peritoneal Cancer AJCC v7 |
Interventions |
Other: Clinical Observation Other: Laboratory Biomarker Analysis Drug: Paclitaxel Drug: Paclitaxel Poliglumex Procedure: Quality-of-Life Assessment |
Enrollment | 1157 |
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Arm I (Paclitaxel Poliglumex) | Arm II (Paclitaxel) | Arm III (Observation) |
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Patients receive polyglutamate paclitaxel IV over 10-20 minutes on day 1.Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Paclitaxel Poliglumex: Given IV Quality-of-Life Assessment: Ancillary studies |
Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies |
Patients receive no further anticancer treatment until evidence of disease progression. Clinical Observation: Undergo observation Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
Period Title: Overall Study | |||
Started | 387 | 384 | 386 |
Completed | 353 | 349 | 349 |
Not Completed | 34 | 35 | 37 |
Reason Not Completed | |||
Withdrawal by Subject | 19 | 12 | 12 |
Never Treated | 8 | 10 | 12 |
Ineligible | 7 | 13 | 13 |
Arm/Group Title | Arm I (Paclitaxel Poliglumex) | Arm II (Paclitaxel) | Arm III (Observation) | Total | |
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Patients receive polyglutamate paclitaxel IV over 10-20 minutes on day 1.Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Paclitaxel Poliglumex: Given IV Quality-of-Life Assessment: Ancillary studies |
Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies |
Patients receive no further anticancer treatment until evidence of disease progression. Clinical Observation: Undergo observation Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
Total of all reporting groups | |
Overall Number of Baseline Participants | 387 | 384 | 386 | 1157 | |
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All enrolled patients.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 387 participants | 384 participants | 386 participants | 1157 participants | |
59.02 (10.89) | 58.80 (10.42) | 59.07 (9.68) | 58.96 (10.34) | ||
Age, Customized
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 387 participants | 384 participants | 386 participants | 1157 participants |
< 40 years |
21 5.4%
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13 3.4%
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11 2.8%
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45 3.9%
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40 - 49 years |
54 14.0%
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71 18.5%
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57 14.8%
|
182 15.7%
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50 - 59 years |
115 29.7%
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114 29.7%
|
138 35.8%
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367 31.7%
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60 - 69 years |
137 35.4%
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132 34.4%
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126 32.6%
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395 34.1%
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70 - 79 years |
56 14.5%
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46 12.0%
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49 12.7%
|
151 13.1%
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>= 80 years |
4 1.0%
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8 2.1%
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5 1.3%
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17 1.5%
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 387 participants | 384 participants | 386 participants | 1157 participants | |
Female |
387 100.0%
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384 100.0%
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386 100.0%
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1157 100.0%
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|
Male |
0 0.0%
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0 0.0%
|
0 0.0%
|
0 0.0%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 387 participants | 384 participants | 386 participants | 1157 participants | |
Hispanic or Latino |
18 4.7%
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25 6.5%
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16 4.1%
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59 5.1%
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Not Hispanic or Latino |
341 88.1%
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338 88.0%
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346 89.6%
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1025 88.6%
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Unknown or Not Reported |
28 7.2%
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21 5.5%
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24 6.2%
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73 6.3%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 387 participants | 384 participants | 386 participants | 1157 participants | |
American Indian or Alaska Native |
1 0.3%
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3 0.8%
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1 0.3%
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5 0.4%
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Asian |
7 1.8%
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11 2.9%
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9 2.3%
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27 2.3%
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Native Hawaiian or Other Pacific Islander |
1 0.3%
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1 0.3%
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1 0.3%
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3 0.3%
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Black or African American |
21 5.4%
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13 3.4%
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17 4.4%
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51 4.4%
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White |
353 91.2%
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352 91.7%
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355 92.0%
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1060 91.6%
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More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Unknown or Not Reported |
4 1.0%
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4 1.0%
|
3 0.8%
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11 1.0%
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Name/Title: | Christopher Purdy on behalf of Austin Miller PhD |
Organization: | NRG Oncology |
Phone: | (716) 845-1300 ext 2296 |
EMail: | purdyc@nrgoncology.org |
Responsible Party: | GOG Foundation |
ClinicalTrials.gov Identifier: | NCT00108745 |
Other Study ID Numbers: |
GOG-0212 NCI-2009-00586 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 07-117 CDR0000422427 GOG-0212 GOG-0212 ( Other Identifier: NRG Oncology ) GOG-0212 ( Other Identifier: CTEP ) U10CA180868 ( U.S. NIH Grant/Contract ) U10CA027469 ( U.S. NIH Grant/Contract ) |
First Submitted: | April 18, 2005 |
First Posted: | April 19, 2005 |
Results First Submitted: | February 22, 2021 |
Results First Posted: | April 1, 2021 |
Last Update Posted: | September 30, 2021 |