Who is sponsoring NCT00006227?

NCT00006227 is sponsored by Gynecologic Oncology Group.

What drugs are being tested in NCT00006227?

Interventions in NCT00006227: Paclitaxel.

What condition does NCT00006227 study?

NCT00006227 studies Adult Type Ovarian Granulosa Cell Tumor, Ovarian Gynandroblastoma, Ovarian Sertoli-Leydig Cell Tumor, Ovarian Sex Cord Tumor With Annular Tubules, Ovarian Steroid Cell Tumor.

Is NCT00006227 still recruiting?

NCT00006227 is currently completed. Last updated 5 March 2020.

Are results published for NCT00006227?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-03-05 · How we verify

NCT00006227

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Paclitaxel in Treating Patients With Ovarian Stromal Cancer

Completed Phase 2 Results posted Last updated 5 March 2020

What this trial tests

Phase 2 trial testing Paclitaxel in Adult Type Ovarian Granulosa Cell Tumor in 31 participants. Completed in 16 July 2016.

Timeline

20 November 2000

Primary endpoint
16 July 2016

16 July 2016

Quick facts

Lead sponsor	Gynecologic Oncology Group
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	31
Start date	20 November 2000
Primary completion	16 July 2016
Estimated completion	16 July 2016
Sites	98 locations across Japan, United States

Drugs / interventions tested

Paclitaxel — full drug profile →

Conditions studied

Adult Type Ovarian Granulosa Cell Tumor — all drugs for Adult Type Ovarian Granulosa Cell Tumor →
Ovarian Gynandroblastoma — all drugs for Ovarian Gynandroblastoma →
Ovarian Sertoli-Leydig Cell Tumor — all drugs for Ovarian Sertoli-Leydig Cell Tumor →
Ovarian Sex Cord Tumor With Annular Tubules — all drugs for Ovarian Sex Cord Tumor With Annular Tubules →

Sponsor

Gynecologic Oncology Group — full company profile →

Who can join

Eligibility, female only, with Adult Type Ovarian Granulosa Cell Tumor or Ovarian Gynandroblastoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Probability of Complete Clinical Response Primary · Up to 5 years

The probability of complete clinical response (i.e. proportion of participants) (assessed using GOG RECIST criteria) of paclitaxel as second line chemotherapy in measurable disease patients with malignant tumors of the ovarian stroma

Group	Value	95% CI
Treatment (Paclitaxel)	3.2	0.74 – 15.30

Progression-free Survival Secondary · The period from study entry until disease progression, death or date of last contact

Duration of progression free survival (median) (months)

Group	Value	95% CI
Treatment (Paclitaxel)	10.0	6.0 – 19.6

Overall Survival Secondary · The observed length of life from entry into the study to death or the date of last contact

Duration of overall survival (median) (months)

Group	Value	95% CI
Treatment (Paclitaxel)	73.6	63.7 – 112.9

Adverse events — posted to ClinicalTrials.gov

Time frame: For the duration of treatment and follow-up. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment (Paclitaxel)

Serious: 1/31 (3%)

Deaths: 16/31

Serious adverse events (6 terms)

Reaction	System	Treatment (Paclitaxel)
Neutrophil count decreased	Investigations	—
White blood cell decreased	Investigations	—
Muscle weakness lower limb	Musculoskeletal and connective tissue disorders	—
Hyperglycemia	Metabolism and nutrition disorders	—
Injection site reaction	General disorders	—
Febrile neutropenia	Blood and lymphatic system disorders	—

Other adverse events (18 terms — click to expand)

Reaction	System	Treatment (Paclitaxel)
Dermatologic	Skin and subcutaneous tissue disorders	—
Pain	General disorders	—
Neutropenia	Blood and lymphatic system disorders	—
Neurologic	Injury, poisoning and procedural complications	—
Anemia	Blood and lymphatic system disorders	—
Leukopenia	Blood and lymphatic system disorders	—
Constitutional	General disorders	—
Gastrointestinal	Gastrointestinal disorders	—
Thrombocytopenia	Investigations	—
Metabolic	Metabolism and nutrition disorders	—
Musculoskeletal	Musculoskeletal and connective tissue disorders	—
Ocular	Eye disorders	—
Hepatic	Hepatobiliary disorders	—
Allergic reaction	Immune system disorders	—
Cardiovascular	Cardiac disorders	—
Genitourinary	Renal and urinary disorders	—
Infection / fever	Infections and infestations	—
Pulmonary	Respiratory, thoracic and mediastinal disorders	—

Most-reported serious reactions: Neutrophil count decreased, White blood cell decreased, Muscle weakness lower limb, Hyperglycemia, Injection site reaction, Febrile neutropenia.

Data from ClinicalTrials.gov NCT00006227 adverse events section.

Sponsor's own description

This phase II trial studies the effectiveness of paclitaxel in treating patients who have ovarian stromal cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Paclitaxel

Trials testing the same drug.

NCT07346196 — A Trial of Locoregionally Advanced Squamous Cell Carcinoma of The Head and Neck · Phase 2 · not yet recruiting
NCT07441681 — Comparing Radiation Plus Cetuximab to Radiation Plus Chemotherapy in People With Head and Neck Cancer Who Cannot Receive · Phase 3 · not yet recruiting
NCT07281417 — Testing the Addition of Cemiplimab (REGN2810) to Chemotherapy Treatment Given Prior to Surgery in Patients With Sinonasa · Phase 2 · recruiting
NCT07195734 — Testing the Addition of Chemotherapy or Chemo-Immunotherapy to the Usual Surgery for Advanced Head and Neck Cancer · Phase 2 · recruiting
NCT07465757 — A Study of Alisertib and Paclitaxel in Patients With Small Cell Lung Cancer (SCLC) · Phase 2 · not yet recruiting

Other Gynecologic Oncology Group trials

Trials by the same sponsor.

NCT04393285 — Abemaciclib and Letrozole to Treat Endometrial Cancer · Phase 2 · active not recruiting
NCT03673124 — Ribociclib and Letrozole Treatment in Ovarian Cancer · Phase 2 · active not recruiting
NCT02065687 — Paclitaxel and Carboplatin With or Without Metformin Hydrochloride in Treating Patients With Stage III, IV, or Recurrent · Phase 2, PHASE3 · unknown
NCT01720173 — Dalantercept in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer · Phase 2 · completed
NCT01406769 — Bioimpedance Spectroscopy in Detecting Lower-Extremity Lymphedema in Patients With Stage I, Stage II, Stage III, or Stag · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00006227 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Gynecologic Oncology Group
Last refreshed: 5 March 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00006227.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing