A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE EFFECT OF CISPLATIN/EPINEPHRINE INJECTABLE GEL (PRODUCT MPI 5010) WHEN ADMINISTERED INTRATUMORALLY FOR ACHIEVEMENT OF TREATMENT GOALS IN RECURRENT OR REFRACTORY SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known if treatment with cisplatin plus epinephrine is effective for head and neck cancer.
PURPOSE: Randomized double-blinded phase III trial to determine the effectiveness of cisplatin plus epinephrine in injectable gel form in treating patients who have recurrent or refractory head and neck cancer.

Start Date01 May 1995

Sponsor / Collaborator

Matrix Pharmaceutical, Inc.

100 Clinical Results associated with Cisplatin/Epinephrine

100 Translational Medicine associated with Cisplatin/Epinephrine

100 Patents (Medical) associated with Cisplatin/Epinephrine

Literatures (Medical) associated with Cisplatin/Epinephrine

01 Mar 2004·Annals of Otology, Rhinology & LaryngologyQ4 · MEDICINE

Phase 2 Study of Intratumoral Cisplatin and Epinephrine Treatment for Locally Recurrent Head and Neck Tumors

Q4 · MEDICINE

Article

Author: Duvillard, Christian ; Cosmidis, Alain ; Beaudouin, Nathalie ; Romanet, Philippe ; Chauffert, Bruno

Local relapses of head and neck tumors are not often eligible for surgical and/or radiotherapy retreatment, and the efficacy of systemic chemotherapy is poor. A greater accumulation and efficacy of anticancer drugs with lower systemic toxicity is theoretically obtained with intratumoral chemotherapy. In experimental studies, epinephrine has been shown to increase the concentration and antitumor effect of intratumoral cisplatin. Fourteen patients with locally recurrent head and neck tumors (median age, 58.7 years) were included in this phase 2 trial. Recurrent tumors (squamous cell carcinomas) were located on the tongue, oral pharynx, or cervical nodes. Prior therapy was surgery and/or radiotherapy with or without intravenous chemotherapy. Inclusion criteria included an Eastern Cooperative Oncology Group/World Health Organization performance status of 0, 1, or 2, an anticipated survival of >3 months, adequate cardiac, kidney, liver, and bone marrow function, and no coagulopathy or carotid invasion. Fifty intratumoral injections of cisplatin-epinephrine (average, 3.6 injections per patient; range, 1 to 5 injections) were given to the 14 patients from November 1998 to July 2000. Patients were treated with cisplatin (1 mg/mL; maximum dose, 50 mg) at an injection volume corresponding to the tumor volume (1 mL/cm3 of tumor; maximum volume, 50 mL). Epinephrine was added at a concentration of 0.02 mg/mL. Intratumoral injections were repeated every 2 to 3 weeks at different locations in the tumors to obtain a homogeneous distribution. Tumor response was evaluated by clinical examination and computed tomography. Eight objective responses were registered among the 14 patients. Four were complete responses, and 4 were partial responses. The average time to disease progression was 11.5 ± 8.9 weeks. Local adverse effects were transient pain, swelling, and erythema at the site of the injection. No nephrotoxicity, neurotoxicity, or ototoxicity was observed. Intratumoral injection of cisplatin and epinephrine in an aqueous solution has a definite antitumor activity in recurrent head and neck cancer with acceptable local tolerance and no major systemic toxic effects except for transient tachycardia and high blood pressure at the time of injection.

15 Feb 2003·Journal of Clinical OncologyQ1 · MEDICINE

Phase II Study of the Efficacy and Safety of Cisplatin-Epinephrine Injectable Gel Administered to Patients With Unresectable Hepatocellular Carcinoma

Q1 · MEDICINE

Article

Author: Orenberg, E.K. ; Leung, T.W.T. ; Stewart, M. ; Gores, G.J. ; Engelmann, K. ; O’Grady, J. ; Heneghan, M. ; Vogl, T.J. ; Johnson, P.J. ; Thuluvath, P.J. ; Yu, S. ; Geschwind, J. ; Giovannini, M.

Purpose: To study the efficacy and safety of percutaneous cisplatin-epinephrine (CDDP-EPI) injectable gel in patients with localized unresectable hepatocellular carcinoma (HCC). Patients and Methods: Eligible patients had histologically proven HCC, no prior treatment except for surgery, and no more than three tumors (each measured ≤ 7 cm, total tumor volume ≤ 200 cm3). They were treated percutaneously under ultrasound or computed tomography (CT) guidance, with up to 10 mL of CDDP-EPI gel (1 mL contains 4 mg of CDDP and 0.1 mg of EPI) per treatment and four treatments in 6 weeks to a maximum of eight treatments. The primary end points were tumor response, defined by change of percentage of tumor necrosis according to CT criteria, and safety. Survival parameters were secondary end points. Results: From June 1997 to April 2000, 58 patients (median age, 65 years) entered the study. All patients were assessable for safety, and 51 were assessable for efficacy. The median number of treatments was four (range, one to eight treatments). Objective response rate was 53% (27 of 51 patients), including 16 complete and 11 partial responses. Of the 27 responders, 14 (52%) subsequently developed progressive disease, but in most of them (93%), a new tumor arose at untreated liver sites. Median survival was 27 months (range, 18.4 to 35.7 months). The 1-, 2-, and 3-year survival rates were 79%, 56%, and 14% respectively. The procedure was well tolerated with only minor side effects. Conclusion: Percutaneous local ablation with CDDP-EPI injectable gel can induce significant tumor necrosis and local control for localized unresectable HCC, and the treatment is well tolerated.

100 Deals associated with Cisplatin/Epinephrine

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Head and Neck Neoplasms	Phase 3	United Kingdom	Novartis AG	-
Head and Neck Neoplasms	Phase 3	Netherlands	Novartis AG	-
Head and Neck Neoplasms	Phase 3	Hong Kong	Novartis AG	-
Head and Neck Neoplasms	Phase 3	Sweden	Novartis AG	-
Head and Neck Neoplasms	Phase 3	Germany	Novartis AG	-
Liver Cancer	Phase 3	-	Novartis Pharma AG	-
Lung Cancer	Phase 3	United States	Novartis AG	-
Lung Cancer	Phase 3	Europe	Novartis AG	-
Lung Cancer	Phase 3	-	Novartis Pharma AG	-
Sarcoma	Phase 3	United States	Novartis AG	-

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


WCLC2018	Not Applicable	Malignant Pleural Mesothelioma	27	Ganetespib	(ipgagivkgx): hazard ratio = 0.32 (95% CI, 0.11 - 0.95), P-Value = 0.04	-	25 Sep 2018
				Pemetrexed and Cisplatin/Carboplatin Chemotherapy
WCLC2015	Not Applicable	Extensive stage Small Cell Lung Cancer	62	Irinotecan/cisplatin (IP)	(bwzkrllfuu) = zmrxfpzujv sfdnkbgaus (fgbbriskyt ) View more	-	08 Sep 2015
				Etoposide/cisplatin (EP)	(bwzkrllfuu) = hajdhnrivs sfdnkbgaus (fgbbriskyt ) View more

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