Trial · NCT00569673

Docetaxel, Trabectedin, and G-CSF or Pegfilgrastim in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Primary Peritoneal Cavity Cancer, or Fallopian Tube Cancer

NCT00569673, Phase 2, Completed, Gynecologic Oncology Group; results first posted 2014-06-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Docetaxel, Trabectedin, and G-CSF or Pegfilgrastim in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Primary Peritoneal Cavity Cancer, or Fallopian Tube Cancer. Trials, record NCT00569673. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00569673

On this page

Trial

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

Title: Docetaxel, Trabectedin, and G-CSF or Pegfilgrastim in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Primary Peritoneal Cavity Cancer, or Fallopian Tube Cancer
NCT number: NCT00569673
Status: Completed
Phases: Phase 2
Enrollment: 71 participants, actual
Lead sponsor: Gynecologic Oncology Group
Conditions: Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
Interventions: filgrastim, pegfilgrastim, docetaxel, trabectedin
First posted: 2007-12-07
Last updated: 2018-07-18
Results first posted: 2014-06-26

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Objective Tumor Response	every other cycle for the first 6 months; then every 3 months thereafter (up to 5 years)	Response is measured according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.0): Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. Disease Progression is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry. Stable Disease is any condition not meeting the above criteria. Indeterminate is defined as having no repeat tumor assessments following initiation of study therapy6
Primary	Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0	Prior to each cycle and 30 days after the last cycle (average of 5 months)
Secondary	Duration of Progression-free Survival and Overall Survival	up to 5 years

Source ClinicalTrials.gov

Outcomes3

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Objective Tumor Response	every other cycle for the first 6 months; then every 3 months thereafter (up to 5 years)	Total number eligible and evaluable	participants	NUMBER
PRIMARY	Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0	Prior to each cycle and 30 days after the last cycle (average of 5 months)	Eligible and treated patients	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Duration of Progression-free Survival and Overall Survival	up to 5 years

Source ClinicalTrials.gov

Results by group20

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

Outcome	Group	Category	Value	Units
Objective Tumor Response	Docetaxel Plus Trabectedin	Partial response	21	participants
Objective Tumor Response	Docetaxel Plus Trabectedin	Stable disease	32	participants
Objective Tumor Response	Docetaxel Plus Trabectedin	Disease progression	17	participants
Objective Tumor Response	Docetaxel Plus Trabectedin	Indeterminate	1	participants
Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0	Docetaxel Plus Trabectedin	Leukopenia	21	Participants
Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0	Docetaxel Plus Trabectedin	Thrombocytopenia	7	Participants
Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0	Docetaxel Plus Trabectedin	Neutropenia	21	Participants
Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0	Docetaxel Plus Trabectedin	Anemia	5	Participants
Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0	Docetaxel Plus Trabectedin	Other hematologic	2	Participants
Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0	Docetaxel Plus Trabectedin	Constitutional	8	Participants

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Docetaxel Plus Trabectedin	71
Overall Study	COMPLETED	Docetaxel Plus Trabectedin	71
Overall Study	NOT COMPLETED	Docetaxel Plus Trabectedin	0

Source ClinicalTrials.gov

Adverse events196

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	Rhinitis	Immune system disorders	Docetaxel Plus Trabectedin	2	71
other	Otitis Middle Ear	Ear and labyrinth disorders	Docetaxel Plus Trabectedin	1	71
other	Hearing (Without Monitoring Program)	Ear and labyrinth disorders	Docetaxel Plus Trabectedin	1	71
other	Tinnitus	Ear and labyrinth disorders	Docetaxel Plus Trabectedin	5	71
other	Neutrophils	Blood and lymphatic system disorders	Docetaxel Plus Trabectedin	37	71
other	Platelets	Blood and lymphatic system disorders	Docetaxel Plus Trabectedin	43	71
other	Blood/Bone Marrow - Other	Blood and lymphatic system disorders	Docetaxel Plus Trabectedin	1	71
other	Leukocytes	Blood and lymphatic system disorders	Docetaxel Plus Trabectedin	40	71
other	Lymphopenia	Blood and lymphatic system disorders	Docetaxel Plus Trabectedin	4	71
other	Hemoglobin	Blood and lymphatic system disorders	Docetaxel Plus Trabectedin	70	71

1 to 10 of 196Source ClinicalTrials.gov

See all 196 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Docetaxel Plus Trabectedin
Total, other adverse events	Docetaxel Plus Trabectedin	71	71
Total, serious adverse events	Docetaxel Plus Trabectedin	31	71

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
21144560	RESULT

Source PubMed

Grants0

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.

None in this release.

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/NCT00569673

GET https://conductscience.org/api/trials/v1/NCT00569673/events?page=2

API reference For AI assistants