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Open-label, multicenter study to evaluate the safety and efficacy of oral etoposide and iv cisplatin for patients with advanced or recurrent cervical cancer

Post-marketing clinical study of Etoposide Capsule in patients with cervical cancer

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080221037
Enrollment
40
Registered
2010-03-08
Start date
2010-03-08
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical cancer

Interventions

investigational material(s) Generic name etc : Etoposide capsule / Cisplatin INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Inv

Sponsors

Nippon Kayaku Co., Ltd.
Lead Sponsor
Bristol-Myers Squibb
Collaborator

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1) Histologically or cytologically or clinically confirmed cervical cancer 2) Measurable lesion 3) Previously untreated Stage IIIB/IV not amenable to curative surgery or radiation therapy, recurrent or persistent disease 4) ECOG PS 0-2 5) Body Weight >= 35 kg 6) Survival period more than 3 months 7) Normal organ function (WBC >= 3,000/mm3, platelets >= 100,000/mm3, hemoglobin >= 9.0g/dL, AST/ALT =< 2 x ULN (patients with liver metastases doesn't have the limitation), total bilirubin =< ULN, serum creatinine =< ULN) 8) Written informed consent

Exclusion criteria

Exclusion criteria:

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026