Neoplasms

Digestive System Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Stomach Neoplasms

Recurrence

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Edotecarin

Pfizer CT.gov Call Center

This will be an international, multicenter, uncontrolled, 2-stage, phase II study in adult patients with advanced gastric cancer, reasonable performance status, good organ function, lack of serious concomitant medical conditions. Patients must have progressed or recurred after a fluoropyrimidine-containing regimen at anytime for primary metastatic disease or within 6 months of last dose of adjuvant therapy. Twenty-one evaluable patients will be enrolled in Stage 1. If at least 2 objective tumor responses are observed in the first 21 evaluable patients, the study will be expanded to enroll a total of 41 evaluable patients. Edotecarin will be administered at a starting dose of 13 mg/m2 as an IV infusion over 60 minutes in repeated 3-week cycles treatment.

Intravenous Edotecarin in Patients With Advanced Gastric Cancer That Has Progressed or Recurred After Chemotherapy

A Phase II Efficacy And Safety Study Intravenous Edotecarin In Patients With Advanced Gastric Cancer That Has Progressed Or Recurred After Prior Fluropyrimidine-Based Chemotherapy

Pfizer

Esophageal Neoplasms

Head and Neck Neoplasms

Esophageal Diseases

Esophageal Cancer

Antineoplastic Agents

All Drugs and Chemicals

Cisplatin

cisplatin

edotecarin

David H. Ilson, MD, PhD

RATIONALE: Drugs used in chemotherapy, such as edotecarin and cisplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Combining edotecarin with cisplatin may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combining edotecarin with cisplatin in treating patients who have advanced or metastatic solid tumors.

OBJECTIVES:

Primary

* Determine the maximum tolerated dose and recommended phase II dose of edotecarin when administered with cisplatin (administered in 2 different schedules) in patients with advanced or metastatic solid tumors.

Secondary

* Determine the safety profile of this regimen in these patients.
* Determine the plasma pharmacokinetics of this regimen in these patients.
* Determine the antitumor activity of this regimen in these patients.

OUTLINE: This is an open-label, multicenter, dose-escalation study of edotecarin. Patients are assigned to 1 of 2 schedules.

* Schedule A: Patients receive cisplatin IV over 30 minutes and edotecarin IV over 1 hour on days 1 and 8.
* Schedule B: Patients receive cisplatin IV over 2 hours and edotecarin IV over 1 hour on day 1.

In both schedules, courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients in each schedule receive escalating doses of edotecarin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 10 additional patients with metastatic esophageal or gastric cancer receive treatment as above at the MTD.

Patients are followed every 2 months for 1 year or until disease progression.

PROJECTED ACCRUAL: A maximum of 80 patients (40 per schedule) will be accrued for this study.

Edotecarin and Cisplatin in Treating Patients With Advanced or Metastatic Solid Tumors

A Phase I Dose Escalation Study of Edotecarin (PHA-782615) and Cisplatin in Adult Patients With Advanced/Metastatic Solid Tumors

National Cancer Institute (NCI)

Memorial Sloan Kettering Cancer Center

Glioblastoma

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Temozolomide

Lomustine

Carmustine

Alkylating Agents

Antineoplastic Agents, Alkylating

Carmustine (BCNU)

Lomustine (CCNU)

The purpose of this clinical trial is to study Edotecarin in patients with the brain tumor glioblastoma multiforme (GBM) who have progression or first recurrence following initial treatment with surgery, radiation and chemotherapy.

Study of IV Edotecarin Vs Temozolomide or Carmustine (BCNU) or Lomustine (CCNU) in Patients With Glioblastoma Multiforme

A Phase III, Randomized, Open-Label Study Of IV Edotecarin Vs Temozolomide Or Carmustine (BCNU) Or Lomustine (CCNU) In Patients With Glioblastoma Multiforme At First Relapse After Alkylator-Based (NEO) Adjuvant Chemotherapy

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Taxane

Andrew D. Seidman, MD

Clifford A. Hudis, MD

RATIONALE: Drugs used in chemotherapy such as edotecarin use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well edotecarin works in treating women with locally advanced or metastatic breast cancer that has not responded to previous chemotherapy.

OBJECTIVES:

Primary

* Determine the antitumor activity of edotecarin in women with anthracycline- and taxane-refractory or chemoresistant locally advanced or metastatic breast cancer.

Secondary

* Determine the time to tumor response and duration of response in patients treated with this drug.
* Determine the overall survival of patients treated with this drug.
* Determine the clinical benefit of this drug in these patients.
* Determine the safety and tolerability of this drug in these patients.
* Determine the pharmacokinetics of this drug in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive edotecarin IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2 months until disease progression.

PROJECTED ACCRUAL: A total of 31-65 patients will be accrued for this study.

Edotecarin in Treating Women With Locally Advanced or Metastatic Breast Cancer That Has Not Responded to Chemotherapy

A Phase II Study of Intravenous Edotecarin (PHA-782615) in Patients With Anthracycline- and Taxane-Refractory or Chemoresistant Metastatic Breast Cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Intravenous Edotecarin in Patients With Advanced Gastric Cancer That Has Progressed or Recurred After Chemotherapy	NCT00087503	Stomach Neoplas...	Edotecarin	18 Years -	Pfizer
Edotecarin and Cisplatin in Treating Patients With Advanced or Metastatic Solid Tumors	NCT00072332	Esophageal Canc... Gastric Cancer Unspecified Adu...	cisplatin edotecarin	18 Years -	National Cancer Institute (NCI)
Study of IV Edotecarin Vs Temozolomide or Carmustine (BCNU) or Lomustine (CCNU) in Patients With Glioblastoma Multiforme	NCT00068952	Glioblastoma	Edotecarin Temozolomide Carmustine (BCN... Lomustine (CCNU...	18 Years -	Pfizer
Intravenous Edotecarin in Patients With Advanced Gastric Cancer That Has Progressed or Recurred After Chemotherapy	NCT00087503	Stomach Neoplas...	Edotecarin	18 Years -	Pfizer
Edotecarin in Treating Women With Locally Advanced or Metastatic Breast Cancer That Has Not Responded to Chemotherapy	NCT00070031	Breast Cancer	edotecarin	18 Years -	National Cancer Institute (NCI)

Spots Global Cancer Trial Database for edotecarin

Every month we try and update this database with for edotecarin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for edotecarin

Every month we try and update this database with for edotecarin cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for edotecarin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.