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Combination of Gemcitabine and Paclitaxel for urothelial carcinoma

Combination of Gemcitabine and Paclitaxel for urothelial carcinoma - Gemcitabine and Paclitaxel for Urothelial carcinoma

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000008357
Enrollment
40
Registered
2012-08-01
Start date
2012-08-01
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

Urothelial carcionoma

Interventions

The regimen is triweekly. Patients receive 200mg/m2 paclitaxel that is administered by intravenous (IV) infusion on Day 1 and 1,000mg/m2 gemcitabine that is administered by IV infusion on Day 1, 8 a

Sponsors

Saiseikai Yokohamashi Tobu Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. written informed consent 2. Urothelial cancer was (must be) confirmed by histological or cytological methods. 3. adjuvant or neoadjuvant setting, locally advanced (T4b, N1-3) or metastatic urothelial cancer who are not eligible for radical surgery 4. Patients had measurable diseases. 5. Regardless of the objectives, CDDP-resistant urothelial cancer or patients who cannot receive cisplatin due to renal dysfunction. 6. PS 0-2 7. Prior chemotherapy with taxan was not allowed.

Exclusion criteria

Exclusion criteria: 1. prior chemotherapy with paclitaxel 2. patients with interstitial pneumoniae and pulmonary fibrosis 3. patients with body fluid with the necessity of drainage or severe edema 4. patients with brain metastasis with the necessity of treatment 5. active double cancer 6. severe or uncontrollable complications 7. patients with allergy to polyoxyethylene castor oil-contain drug (e.g., CDDP) or sclerosing castor oil-contain drug (e.g., injectable vitamins) 8. Not eligible for patients during Pregnancy or Lactation, and with the hope of pregnancy 9. Prior therapy is allowed if this is completed more than 28 days before study entry. 10. Otherwise, patients are judged to be not eligible by the attending doctor.

Design outcomes

Primary

MeasureTime frame
overall survival, disease specific survival, side effect

Secondary

MeasureTime frame
tumor size, symptom

Countries

Japan

Contacts

Public ContactMasaru Ishida

Saiseikai Yokohamashi Tobu Hospital Urology

m-ishida@kc5.so-net.ne.jp045-576-3000

Outcome results

None listed

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