NCT00623064

Phase I Study of Cisplatin, Gemcitabine and Lapatinib as First Line Treatment in Advanced/Metastatic Urothelial Cancer

Completed Phase 1 Last updated 30 June 2014

What this trial tests

Phase 1 trial testing cisplatin in Bladder Cancer in 18 participants. Completed in 1 August 2012.

Timeline

1 November 2007

Primary endpoint
1 June 2012

1 August 2012

Quick facts

Lead sponsor	European Organisation for Research and Treatment of Cancer - EORTC
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	18
Start date	1 November 2007
Primary completion	1 June 2012
Estimated completion	1 August 2012
Sites	1 location across Denmark

Drugs / interventions tested

• cisplatin (cisplatin) — full drug profile →
• gemcitabine hydrochloride — full drug profile →
• lapatinib ditosylate
• pharmacological study — full drug profile →

Conditions studied

• Bladder Cancer — all drugs for Bladder Cancer →
• Transitional Cell Cancer of the Renal Pelvis and Ureter — all drugs for Transitional Cell Cancer of the Renal Pelvis and Ureter →

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC — full company profile →

Who can join

18 and older, any sex, with Bladder Cancer or Transitional Cell Cancer of the Renal Pelvis and Ureter. 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.

• Maximum tolerated dose of lapatinib ditosylate in combination with cisplatin/gemcitabine hydrochloride and cisplatin/gemcitabine hydrochloride based on the documentation of the acute dose-limiting toxicity in course 1

Sponsor's own description

RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin, and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving lapatinib together with combination chemotherapy may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of lapatinib when given together with cisplatin and gemcitabine as first-line therapy in treating patients with locally advanced or metastatic urothelial cancer.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. HER2-targeted therapies in cancer: a systematic review.
   Zhu K, Yang X, Tai H, Zhong X, et al · · 2024 · cited 83× · PMID 38308374 · DOI 10.1186/s40364-024-00565-1
2. A randomized phase 2 trial of gemcitabine/cisplatin with or without cetuximab in patients with advanced urothelial carcinoma.
   Hussain M, Daignault S, Agarwal N, Grivas PD, et al · · 2014 · cited 75× · PMID 24802654 · DOI 10.1002/cncr.28767
3. Urothelial carcinomas: a focus on human epidermal receptors signaling.
   Grivas PD, Day M, Hussain M. · · 2011 · cited 38× · PMID 21904656
4. Targeted therapies in urothelial carcinoma.
   Ghosh M, Brancato SJ, Agarwal PK, Apolo AB. · · 2014 · cited 37× · PMID 24685646 · DOI 10.1097/cco.0000000000000064
5. Muscle-invasive urothelial bladder cancer: an update on systemic therapy.
   Knollman H, Godwin JL, Jain R, Wong YN, et al · · 2015 · cited 30× · PMID 26622317 · DOI 10.1177/1756287215607418
6. Comparison of global versus epidermal growth factor receptor pathway profiling for prediction of lapatinib sensitivity in bladder cancer.
   Havaleshko DM, Smith SC, Cho H, Cheon S, et al · · 2009 · cited 26× · PMID 19881954 · DOI 10.1593/neo.09898
7. Update on chemotherapy in the treatment of urothelial carcinoma.
   Costantini C, Millard F. · · 2011 · cited 16× · PMID 22125450 · DOI 10.1100/2011/590175
8. Elevating the Horizon: Emerging Molecular and Genomic Targets in the Treatment of Advanced Urothelial Carcinoma.
   Kurtoglu M, Davarpanah NN, Qin R, Powles T, et al · · 2015 · cited 15× · PMID 25862322 · DOI 10.1016/j.clgc.2015.02.009