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NCT00303888
A Randomized Placebo-Controlled Phase Ib/IIa Safety, Tolerability and Efficacy Study of Oral Phenoxodiol in Combination With Docetaxel Versus Docetaxel Alone in Patients With Recurrent Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer
Phase 1 trial testing docetaxel in Fallopian Tube Cancer in 31 participants. Terminated before completion.
1 August 2009
Quick facts
| Lead sponsor | Yale University |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 31 |
| Start date | 1 May 2006 |
| Primary completion | 1 August 2009 |
| Estimated completion | 1 October 2009 |
| Sites | 1 location across United States |
Drugs / interventions tested
Conditions studied
- Fallopian Tube Cancer — all drugs for Fallopian Tube Cancer →
- Ovarian Cancer — all drugs for Ovarian Cancer →
- Primary Peritoneal Cavity Cancer — all drugs for Primary Peritoneal Cavity Cancer →
Sponsor
Yale University
Who can join
Adults 18 to 120, female only, with Fallopian Tube Cancer or Ovarian Cancer. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
- Survival (progression-free/recurrence-free interval and overall survival)
- Tumor response as assessed by RECIST criteria and clinical examination
- Changes in tumor marker CA125 as assessed by Rustin criteria
- Safety
Sponsor's own description
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Phenoxodiol may help docetaxel work better by making tumor cells more sensitive to the drug. PURPOSE: This randomized phase I/II trial is studying the side effects of docetaxel when given together with either phenoxodiol or placebo and to see how well it works in treating patients with recurrent advanced ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Targeting tumor ubiquitin-proteasome pathway with polyphenols for chemosensitization.
Shen M, Chan TH, Dou QP. · · 2012 · cited 41× · PMID 22292765 · DOI 10.2174/187152012802649978
Verify or expand the search:
- PubMed search for NCT00303888
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of docetaxel
Trials testing the same drug.
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- NCT06012435 — A Study of SGN-B6A Versus Docetaxel in Previously Treated Non-small Cell Lung Cancer · Phase 3 · active not recruiting
- NCT07335081 — ctDNA in HER2+ EBC Neoadjuvant Treatment · Phase 2 · recruiting
- NCT05848011 — A Study of Lorigerlimab With Docetaxel or Docetaxel Alone in Participants With Metastatic Castration-Resistant Prostate · Phase 2 · completed
Other recruiting trials for Fallopian Tube Cancer
Currently open trials in the same condition.
- NCT07402915 — Drug-drug Interaction Study With AZD5335 and Itraconazole in Participants With Ovarian, Primary Peritoneal, or Fallopian · Phase 1 · recruiting
- NCT06915025 — Phase 3 Trial Evaluating the Safety & Efficacy of IMNN-001 Administered in Combination w/ Standard NACT & Adjuvant Chemo · Phase 3 · recruiting
- NCT06787612 — Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer · Phase 2 · recruiting
- NCT07023484 — Personalized Timing of Interval Debulking Surgery in Advanced Ovarian Cancer · Phase 2 · recruiting
- NCT07460180 — The PROOV Study: Exploiting the Synergistic Effect of PARP Inhibition With Cisplatin and Hyperthermia During Interval Cy · Phase 1, PHASE2 · recruiting
Other Yale University trials
Trials by the same sponsor.
- NCT06900998 — Pilot Study: Effects of Nimodipine on Alcohol Drinking · Phase 2 · not yet recruiting
- NCT04910984 — Developing a Chatbot to Promote HIV Testing · NA · not yet recruiting
- NCT07458087 — Accuracy of the Accuro 3S · NA · not yet recruiting
- NCT07398404 — A Multiple Health Behavior Change (MHBC) Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Pa · Phase 1, PHASE2 · not yet recruiting
- NCT07305324 — Improving Liver Fibrosis Diagnosis in Primary Care Using FibroX AI · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00303888 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Yale University
- Last refreshed: 12 January 2018
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/NCT00303888.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing