Neoplasms

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Paclitaxel

Albumin-Bound Paclitaxel

Carboplatin

Vadimezan

ASA404

Novartis Pharmaceuticals

This study is designed to obtain pharmacokinetic data following a single-dose 20-minute i.v. administration of ASA404 (900, 1200, or 1800 mg/m2) in adult cancer patients with varying degrees of hepatic impairment. The study will be carried out in cancer volunteer patients (utilizing controls with normal hepatic function) who will be assigned to four hepatic impairment groups according to their pre-dose (Day-1) and total bilirubin level. The study will consist of two phases, a (Core Phase) that will evaluate the pharmacokinetics of a single i.v. dose (900, 1200 and 1800 mg/m2) of ASA404 in adult cancer patients with impaired hepatic function, and compared to controls with normal hepatic function. The assessments will be done on the safety and tolerability of that single dose in adult cancer patients with impaired hepatic function and compared to controls with normal hepatic function. The Extension Phase will consist of assessing the safety and tolerability of ASA404 at the same three doses in combination with a sponsor-approved taxane-based regimen in adult cancer patients with impaired hepatic function and compared to controls with normal hepatic function.

An Open-label, Dose Escalation Study to Assess the Pharmacokinetics of of ASA404 in Adult Cancer Patients With Impaired Hepatic Function

A Multi-center, Open-label, Dose-escalation Study to Assess the Pharmacokinetics of ASA404 in Adult Cancer Patients With Impaired Hepatic Function and With Normal Hepatic Function

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Renal Insufficiency

Neoplastic Processes

Kidney Diseases

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

ASA404, DMXAA or DXAA

The purpose of this study is to evaluate the safety and pharmacokinetics of ASA404 in patients with refractory or relapsed metastatic cancer with impaired renal function and with normal renal function. It is very possible that patients with renal impairment will show differences in renal excretion of parent ASA404 and its metabolites, warranting a study that leads to a better pharmacokinetic assesssment in this population.

A Dose-escalation Pharmacokinetic Study of Intravenous ASA404 in Adult Advanced Cancer Patients With Impaired Renal Function and Patients With Normal Renal Function

A Multi-center, Open-label, Dose-escalation Study to Assess the Pharmacokinetics of Intravenous ASA404 in Adult Advanced Cancer Patients With Impaired Renal Function and With Normal Renal Function

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Nasopharyngeal Carcinoma

Carcinoma

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Gemcitabine

Cisplatin

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Patients receive cisplatin IV over 2 hours once weekly on weeks 1-8 and undergo intensity-modulated radiotherapy once daily, 5 days a week, on weeks 1-7 (6½ weeks for a total of 33 fractions).

Patients receive induction chemotherapy comprising gemcitabine hydrochloride IV over 30 minutes, carboplatin IV over 1 hour, and paclitaxel IV over 1 hour on days 1 and 8. Treatment repeats every 21 days for 3 courses. Beginning at least 3 weeks after the last dose of induction chemotherapy, patients receive cisplatin and undergo radiotherapy as in arm I.

carboplatin,

cisplatin

gemcitabine hydrochloride

paclitaxel

Given once daily 5 days a week for 6½ weeks.

intensity-modulated radiation therapy

Terence Tan, FRCR

RATIONALE: Drugs used in chemotherapy, such as cisplatin, gemcitabine hydrochloride, carboplatin, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy together with radiation therapy my kill more tumor cells. It is not yet known whether giving cisplatin together with radiation therapy is more effective with or without gemcitabine hydrochloride, carboplatin, and paclitaxel in treating patients with nasopharyngeal cancer.

PURPOSE: This randomized phase II/III trial is studying how well giving cisplatin together with radiation therapy works compared with giving cisplatin and radiation therapy together with gemcitabine hydrochloride, carboplatin, and paclitaxel in treating patients with locally advanced nasopharyngeal cancer.

OBJECTIVES:

Primary

* To compare the 5-year overall survival of patients with locally advanced nasopharyngeal cancer treated with concurrent cisplatin and radiotherapy with vs without induction chemotherapy comprising gemcitabine hydrochloride, carboplatin, and paclitaxel.

Secondary

* To assess and compare the disease-free survival, distant metastases rate, toxicities, and quality of life of patients treated with these regimens.

OUTLINE: Patients are stratified by N-stage (N0-1 vs N2-3) and are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive cisplatin IV over 2 hours once weekly on weeks 1-8 and undergo intensity-modulated radiotherapy once daily, 5 days a week, on weeks 1-7 (6½ weeks for a total of 33 fractions).
* Arm II: Patients receive induction chemotherapy comprising gemcitabine hydrochloride IV over 30 minutes, carboplatin IV over 1 hour, and paclitaxel IV over 1 hour on days 1 and 8. Treatment repeats every 21 days for 3 courses. Beginning at least 3 weeks after the last dose of induction chemotherapy, patients receive cisplatin and undergo radiotherapy as in arm I.

Quality of life is assessed periodically.

After completion of study treatment, patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.

Cisplatin and RT With or Without Gemcitabine, Carboplatin, and Paclitaxel in Treating Patients With Locally Advanced NPC

A Randomised Phase II/III Study of Concurrent Cisplatin-Radiotherapy With or Without Induction Chemotherapy Using Gemcitabine, Carboplatin and Paclitaxel in Locally Advanced Nasopharyngeal Cancer

National Cancer Centre, Singapore

Senior Consultant

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
An Open-label, Dose Escalation Study to Assess the Pharmacokinetics of of ASA404 in Adult Cancer Patients With Impaired Hepatic Function	NCT01278849	Histologically-...	ASA404	18 Years -	Novartis
A Dose-escalation Pharmacokinetic Study of Intravenous ASA404 in Adult Advanced Cancer Patients With Impaired Renal Function and Patients With Normal Renal Function	NCT01278758	Metastatic Canc...	ASA404, DMXAA o...	18 Years -	Novartis
An Open-label, Dose Escalation Study to Assess the Pharmacokinetics of of ASA404 in Adult Cancer Patients With Impaired Hepatic Function	NCT01278849	Histologically-...	ASA404	18 Years -	Novartis
Cisplatin and RT With or Without Gemcitabine, Carboplatin, and Paclitaxel in Treating Patients With Locally Advanced NPC	NCT00997906	Head and Neck C...	carboplatin, cisplatin gemcitabine hyd... paclitaxel intensity-modul...	18 Years -	National Cancer Centre, Singapore
Cisplatin and RT With or Without Gemcitabine, Carboplatin, and Paclitaxel in Treating Patients With Locally Advanced NPC	NCT00997906	Head and Neck C...	carboplatin, cisplatin gemcitabine hyd... paclitaxel intensity-modul...	18 Years -	National Cancer Centre, Singapore

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