Trial · NCT00108745

Paclitaxel, Polyglutamate Paclitaxel, or Observation in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Peritoneal Cancer, or Fallopian Tube Cancer

NCT00108745, Phase 3, Unknown, GOG Foundation; results first posted 2021-04-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Paclitaxel, Polyglutamate Paclitaxel, or Observation in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Peritoneal Cancer, or Fallopian Tube Cancer. Trials, record NCT00108745. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00108745

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Paclitaxel, Polyglutamate Paclitaxel, or Observation in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Peritoneal Cancer, or Fallopian Tube Cancer
NCT number: NCT00108745
Status: Unknown
Phases: Phase 3
Enrollment: 1,157 participants, actual
Lead sponsor: GOG Foundation
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: Clinical Observation, Laboratory Biomarker Analysis, Paclitaxel, Paclitaxel Poliglumex, Quality-of-Life Assessment
First posted: 2005-04-19
Last updated: 2021-09-30
Results first posted: 2021-04-01

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Overall Survival	All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next five years.	Overall survival (OS) was defined as the number of months between study enrollment and death from any cause. Patients still alive at the last follow-up were censored on the date of last contact.
Secondary	Progression-free Survival	Progression was assessed every 8 weeks for the first 15 months, then every 3 months, up to 14.2 years.	Progression free survival (PFS) was defined as the number of months between study enrollment and the date of first clinical, biochemical, or radiological evidence of progression or death due to any cause. Patients who were alive without progression at the time of analysis were censored on the date of the last tumor assessment.
Secondary	Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0	Measured within 6 months of enrollment; through all cycles of chemotherapy and up to 30 days after the last cycle of chemotherapy. Up to 10 cycles of chemotherapy were allowed. Cycles were to be repeated every 3 weeks.	Number of treated patients with Adverse Events (grade 3 or higher) observed while receiving randomized therapy among adverse event terms with at least 4 patients reporting.
Secondary	Patient-Reported Quality of Life (QOL)	1. Prior to treatment 2. Prior to cycle 3 3. Prior to cycle 5 4. Prior to cycle 7 5. Prior to cycle 12 6. 12 months post treatment	Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for ovarian cancer (FACT-O TOI). The FACT-En TOI is a scale for assessing general QOL of ovarian cancer patients. The FACT-O TOI score ranges 0-100 with a large score suggesting better QOL.
Secondary	Patient-Reported Peripheral Neuropathy Symptoms	1. Prior to treatment 2. Prior to cycle 3 3. Prior to cycle 5 4. Prior to cycle 7 5. Prior to cycle 12 6. 12 months post treatment	Patient reported peripheral neuropathy symptoms was measured with the Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The Ntx score ranges 0-16 with a large score suggesting less peripheral neuropathy symptoms.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Overall Survival	All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next five years.	All randomized	Months	MEDIAN
SECONDARY	Progression-free Survival	Progression was assessed every 8 weeks for the first 15 months, then every 3 months, up to 14.2 years.	All randomized	Months	MEDIAN
SECONDARY	Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0	Measured within 6 months of enrollment; through all cycles of chemotherapy and up to 30 days after the last cycle of chemotherapy. Up to 10 cycles of chemotherapy were allowed. Cycles were to be repeated every 3 weeks.	Treated with randomized therapy	participants	NUMBER
SECONDARY	Patient-Reported Quality of Life (QOL)	1. Prior to treatment 2. Prior to cycle 3 3. Prior to cycle 5 4. Prior to cycle 7 5. Prior to cycle 12 6. 12 months post treatment	Provided baseline and \>= 1 follow-up assessment	score on a scale	MEAN
SECONDARY	Patient-Reported Peripheral Neuropathy Symptoms	1. Prior to treatment 2. Prior to cycle 3 3. Prior to cycle 5 4. Prior to cycle 7 5. Prior to cycle 12 6. 12 months post treatment	Provided baseline and \>= 1 follow-up assessment	score on a scale	MEAN

Source ClinicalTrials.gov

Results by group105

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Overall Survival	Arm I (Paclitaxel Poliglumex)		60.0	95% Confidence Interval 51.7 to 68.6	Months
Overall Survival	Arm II (Paclitaxel)		56.8	95% Confidence Interval 47.3 to 65.9	Months
Overall Survival	Arm III (Observation)		58.3	95% Confidence Interval 51.9 to 72.5	Months
Progression-free Survival	Arm I (Paclitaxel Poliglumex)		16.3	95% Confidence Interval 14.4 to 18.9	Months
Progression-free Survival	Arm II (Paclitaxel)		18.9	95% Confidence Interval 17.0 to 21.8	Months
Progression-free Survival	Arm III (Observation)		13.4	95% Confidence Interval 11.2 to 15.7	Months
Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0	Arm I (Paclitaxel Poliglumex)	Allergic Reaction / Hypersensitivity	4		participants
Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0	Arm II (Paclitaxel)	Allergic Reaction / Hypersensitivity	0		participants
Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0	Arm III (Observation)	Allergic Reaction / Hypersensitivity	0		participants
Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0	Arm I (Paclitaxel Poliglumex)	Dehydration	4		participants

1 to 10 of 105Source ClinicalTrials.gov

See all 105 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm I (Paclitaxel Poliglumex)	387
Overall Study	STARTED	Arm II (Paclitaxel)	384
Overall Study	STARTED	Arm III (Observation)	386
Overall Study	COMPLETED	Arm I (Paclitaxel Poliglumex)	353
Overall Study	COMPLETED	Arm II (Paclitaxel)	349
Overall Study	COMPLETED	Arm III (Observation)	349
Overall Study	NOT COMPLETED	Arm I (Paclitaxel Poliglumex)	34
Overall Study	NOT COMPLETED	Arm II (Paclitaxel)	35
Overall Study	NOT COMPLETED	Arm III (Observation)	37

Source ClinicalTrials.gov

Adverse events1,182

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Allergy/Immunology - Other	Immune system disorders	Arm I (Paclitaxel Poliglumex)	1	379
other	Allergy/Immunology - Other	Immune system disorders	Arm II (Paclitaxel)	1	374
other	Allergy/Immunology - Other	Immune system disorders	Arm III (Observation)	2	386
other	Allergic Reaction/Hypersensitivity	Immune system disorders	Arm I (Paclitaxel Poliglumex)	26	379
other	Allergic Reaction/Hypersensitivity	Immune system disorders	Arm II (Paclitaxel)	12	374
other	Allergic Reaction/Hypersensitivity	Immune system disorders	Arm III (Observation)	4	386
other	Rhinitis	Immune system disorders	Arm I (Paclitaxel Poliglumex)	19	379
other	Rhinitis	Immune system disorders	Arm II (Paclitaxel)	31	374
other	Rhinitis	Immune system disorders	Arm III (Observation)	19	386
other	Autoimmune Reaction	Immune system disorders	Arm I (Paclitaxel Poliglumex)	0	379

1 to 10 of 1,182Source ClinicalTrials.gov

See all 1,182 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm I (Paclitaxel Poliglumex)	235	387
Total, all-cause mortality	Arm II (Paclitaxel)	242	384
Total, all-cause mortality	Arm III (Observation)	230	386
Total, other adverse events	Arm I (Paclitaxel Poliglumex)	378	379
Total, other adverse events	Arm II (Paclitaxel)	372	374
Total, other adverse events	Arm III (Observation)	312	386
Total, serious adverse events	Arm I (Paclitaxel Poliglumex)	50	379
Total, serious adverse events	Arm II (Paclitaxel)	39	374
Total, serious adverse events	Arm III (Observation)	1	386

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
35759733	DERIVED

Source PubMed

Grants2

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years	Source
U10CA180868	NRG Oncology Network Group Operations Center	WOLMARK, NORMAN; Le, Quynh-Thu Xuan; MANNEL, ROBERT S.	NRG ONCOLOGY FOUNDATION, INC.	NATIONAL CANCER INSTITUTE	2014 to 2026	NIH RePORTER
U10CA027469	Gynecologic Oncology Group	DISAIA, PHILIP J.	GYNECOLOGIC ONCOLOGY GROUP	NATIONAL CANCER INSTITUTE	1985 to 2013	NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00108745

GET https://conductscience.org/api/trials/v1/NCT00108745/results?page=2

API reference For AI assistants