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NCT00001426
A Multi-Institutional Phase II Study of Cyclophosphamide, Paclitaxel, Cisplatin With G-CSF for Patients With Newly Diagnosed Advanced Stage Ovarian Cancer
Phase 2 trial testing Cyclophosphamide in Ovarian Neoplasm in 66 participants. Completed in 7 November 2013.
15 October 2007
Quick facts
| Lead sponsor | National Cancer Institute (NCI) |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Primary purpose | treatment |
| Enrollment | 66 |
| Start date | 3 February 1995 |
| Primary completion | 15 October 2007 |
| Estimated completion | 7 November 2013 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Cyclophosphamide (cyclophosphamide) — full drug profile →
- Paclitaxel — full drug profile →
- Cisplatin (cisplatin) — full drug profile →
- G-CSF
Conditions studied
- Ovarian Neoplasm — all drugs for Ovarian Neoplasm →
Sponsor
National Cancer Institute (NCI)
Who can join
Eligibility, female only, with Ovarian Neoplasm. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A supra-additive cytotoxic effect was seen when CAI and paclitaxel were given to human ovarian cancer cells sequentially in tissue culture. We have demonstrated that CAI given for 8 days followed by paclitaxel is reasonably well tolerated and that paclitaxel administration causes a dose-dependent increase in CAI plasma concentration. CAI is a cytostatic drug and continuous exposure is needed. This study will evaluate the combination of continuously administered CAI with three-weekly paclitaxel.
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:
- PubMed search for NCT00001426
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Ovarian Neoplasm
Currently open trials in the same condition.
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Other National Cancer Institute (NCI) trials
Trials by the same sponsor.
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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 NCT00001426 (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 National Cancer Institute (NCI)
- Last refreshed: 5 April 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/NCT00001426.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing