Phase I study of Cisplatin, gemcitabin (+ paclitaxel) and lapatinib as first line treatment in advanced/metastatic urothelial cancer

Phase I study of Cisplatin, gemcitabin (+ paclitaxel) and lapatinib as first line treatment in advanced/metastatic urothelial cancer - EORTC protocol 30061

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON31194

Enrollment

Registered

2007-08-22

Start date

2007-10-01

Completion date

Unknown

Last updated

2024-05-13

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

Conditions

urothelial cancer

Interventions

Two combinations will be investigated in this trial: 1.Gemcitabine/Cisplatin/Lapatinib (q4wks) Gemcitabine: 1000 mg/m² days 1, 8, 15 Cisplatin: 70 mg/m² day 2 Lapatinib: d1-28, 750 mg/d to 1500 mg/d

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Histologically proven TCC of the urothelial tract in patients who overexpress HER1 and/or HER2 (IHC 2/3+ FISH/CISH +) - Metastatic or locally advanced disease with involvement of at least one target not in previously irradiated fields - Tissue from the primary or metastatic site must be available for biomarker status determination - Measurable disease according to RECIST - Normal bone marrow, renal, hepatic and cardiac functions

Exclusion criteria

Exclusion criteria: - No prior chemotherapy for metastatic disease. - No radiotherapy within the last 4 weeks before inclusion - Drugs which are inducers or inhibitors of CYP3A4 are prohibited

Design outcomes

Primary

Measure	Time frame
To identify the maximum tolerated dose (MTD) of Lapatinib in combination with cisplatin/gemcitabine and cisplatin/gemcitabine/paclitaxel based on the documentation of the acute dose limiting toxicity (DLT) in cycle 1.	—

Secondary

Measure	Time frame
- To determine the pharmacokinetic profile of Lapatinib in combination with cisplatin/gemcitabine and cisplatin/gemcitabine/paclitaxel - To assess the anti-tumor activity according to RECIST, in those patients with measurable disease - To explore the patient population by determination of intra-tumoral expression levels of relevant biomarkers from tumor tissue: three Erb/EGFR family members (HER1, HER2,HER3, HER4), AKT (58kDa serine/threonine protein kinase), TUNEL, p53 , MAPK and Insulin-like growth factor-1 (IGF-1R) and potentially other signalling pathways likeVEGF together with biomarkers that are downstream of these receptors.	—

Measure

Time frame

- To determine the pharmacokinetic profile of Lapatinib in combination with cisplatin/gemcitabine and cisplatin/gemcitabine/paclitaxel - To assess the anti-tumor activity according to RECIST, in those patients with measurable disease - To explore the patient population by determination of intra-tumoral expression levels of relevant biomarkers from tumor tissue: three Erb/EGFR family members (HER1, HER2,HER3, HER4), AKT (58kDa serine/threonine protein kinase), TUNEL, p53 , MAPK and Insulin-like growth factor-1 (IGF-1R) and potentially other signalling pathways likeVEGF together with biomarkers that are downstream of these receptors.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)