Neoplasms

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Carcinoma, Squamous Cell

Recurrence

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Antineoplastic Agents

All Drugs and Chemicals

Exatecan

Topoisomerase I Inhibitors

Enzyme Inhibitors

exatecan mesylate

Robert L. DeJager, MD, FACP

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

PURPOSE: Phase II trial to study the effectiveness of DX-8951f in treating women who have advanced or recurrent cancer of the cervix.

OBJECTIVES:

* Determine the antitumor activity of DX-8951f in women with advanced or recurrent squamous cell carcinoma of the cervix.
* Evaluate the quantitative and qualitative toxic effects of this regimen in these patients.
* Evaluate the pharmacokinetics of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive DX-8951f IV over 30 minutes daily for 5 days. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months until death.

PROJECTED ACCRUAL: Approximately 37 patients will be accrued for this study.

DX-8951f in Treating Women Who Have Advanced or Recurrent Cancer of the Cervix

A Phase II Study of Intravenous DX-8951f Administered Daily for Five Days Every Three Weeks to Patients With Advanced or Recurrent Squamous Cell Cancer of the Cervix

Daiichi Sankyo

Digestive System Diseases

Rare Diseases

Cholangiocarcinoma

Liver Neoplasms

Gallbladder Neoplasms

Bile Duct Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Biliary Tract Neoplasms

Biliary Tract Diseases

Gallbladder Diseases

Bile Duct Diseases

Bile Duct Cancer

Biliary Tract Cancer

Gallbladder Cancer

Hematinics

Liver Extracts

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

PURPOSE: Phase II trial to study the effectiveness of DX-8951f in treating patients who have biliary cancer.

OBJECTIVES: I. Determine the antitumor activity of DX-8951f in terms of antitumor response, response duration, and survival in patients with biliary tree cancer. II. Evaluate the quantitative and qualitative toxicities of this treatment regimen in this patient population. III. Evaluate the pharmacokinetics of DX-8951 in plasma.

OUTLINE: Patients receive DX-8951f IV over 30 minutes daily for 5 days. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for survival.

PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 12 months.

DX-8951f in Treating Patients With Biliary Cancer

A Phase II Study of Intravenous DX-8951f Administered Daily for Five Days Every Three Weeks to Patients With Biliary Tree Cancer (Cholangiocarcinoma and Gallbladder Cancer)

Stomach Neoplasms

Esophageal Neoplasms

Stomach Diseases

Head and Neck Neoplasms

Esophageal Diseases

Stomach Cancer

Esophageal Cancer

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

PURPOSE: Phase II trial to study the effectiveness of exatecan mesylate in treating patients who have metastatic stomach cancer.

OBJECTIVES:

* Determine the objective response rate of patients with previously untreated metastatic gastric cancer treated with exatecan mesylate (DX-8951f).
* Determine the time to tumor progression in this patient population when treated with this drug.
* Determine the survival at 6 and 12 months in this patient population when treated with this drug.
* Determine the quantitative and qualitative toxic effects of this drug in this patient population.
* Determine the pharmacokinetics of this drug in the plasma of these patients.

OUTLINE: This is a multicenter study.

Patients receive exatecan mesylate (DX-8951f) IV over 30 minutes on days 1-5. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 12 months.

DX-8951f in Treating Patients With Metastatic Stomach Cancer

A Phase II Study Of Intravenous Exatecan Mesylate (DX-891F) Administered Daily For Five Days Every Three Weeks To Patients With Previously Untreated Metastatic Gastric Cancer

Blood and Lymph Conditions

Immune System Diseases

Syndrome

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Preleukemia

Leukemia, Myelomonocytic, Chronic

Leukemia, Myelomonocytic, Juvenile

Myelodysplastic Syndromes

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Anemia

Hematologic Neoplasms

Leukemia, Lymphocytic, Chronic, B-Cell

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Anemia, Refractory, with Excess of Blasts

Anemia, Refractory

Blast Crisis

Hematologic Diseases

Bone Marrow Diseases

Precancerous Conditions

Chronic Disease

Disease Attributes

Myeloproliferative Disorders

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Chronic Myelomonocytic Leukemia

Juvenile Myelomonocytic Leukemia

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Chronic Myeloid Leukemia

Acute Graft Versus Host Disease

Childhood Acute Lymphoblastic Leukemia

Myelodysplastic Syndrome With Excess Blasts

Chronic Myeloproliferative Disorders

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

PURPOSE: Phase I trial to study the effectiveness of DX-8951f in treating patients who have hematologic cancer.

OBJECTIVES: I. Determine the maximum tolerated dose of DX-8951f in patients with advanced myelodysplastic syndromes, refractory acute myeloid or lymphocytic leukemia, refractory or transformed chronic lymphocytic leukemia, or chronic myelogenous leukemia in blastic phase. II. Evaluate the quantitative and qualitative toxic effects of this regimen and determine the duration and reversibility of these effects in these patients. III. Make a preliminary determination of the antileukemic activity of this regimen in these patients. IV. Evaluate the pharmacokinetics of this regimen in these patients.

OUTLINE: This is a dose escalation study. Patients receive DX-8951f IV over 30 minutes daily for 5 days. Treatment continues every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of DX-8951f until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose limiting toxicity. Patients are followed every 3 months until death.

PROJECTED ACCRUAL: Approximately 20-25 evaluable patients will be accrued for this study.

Chemotherapy in Treating Patients Who Have Hematologic Cancer

A Phase I Study of Intravenous DX-8951f in Patients With Advanced Myelodysplastic Syndromes, Refractory Acute Leukemia, Refractory or Transformed Chronic Lymphocytic Leukemia, and Chronic Myelogenous Leukemia in Blastic Phase

Sarcoma

Rhabdomyosarcoma

Neoplasms, Connective and Soft Tissue

Myosarcoma

Soft Tissue Sarcoma

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

PURPOSE: Phase II trial to study the effectiveness of exatecan mesylate in treating children who have relapsed or refractory rhabdomyosarcoma.

OBJECTIVES:

* Determine the objective response rate (complete and partial responses) in pediatric patients with relapsed or refractory rhabdomyosarcoma treated with exatecan mesylate.
* Determine the time to tumor progression in patients treated with this drug.
* Determine the median survival and survival at 6 and 12 months in patients treated with this drug.
* Assess pain in patients treated with this drug.
* Evaluate the quantitative and qualitative toxic effects of this drug in these patients.
* Evaluate the pharmacokinetics of this drug in these patients.

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

Patients receive exatecan mesylate IV over 30 minutes on days 1-5. Treatment repeats every 3 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 6 additional courses beyond CR.

PROJECTED ACCRUAL: A total of 13-27 patients will be accrued for this study within 1 year.

Exatecan Mesylate in Treating Children With Relapsed or Refractory Rhabdomyosarcoma

A Phase II Study Of Intravenous DX-8951f (EXATECAN MESYLATE) Administered Daily For Five Days Every Three Weeks To Pediatric Patients With Relapsed Or Refractory Rhabdomyosarcoma

Nervous System Diseases

Osteosarcoma

Liposarcoma

Histiocytoma, Malignant Fibrous

Fibrosarcoma

Histiocytoma

Histiocytoma, Benign Fibrous

Hemangiosarcoma

Leiomyosarcoma

Sarcoma, Synovial

Neurofibrosarcoma

Solitary Fibrous Tumors

Hemangiopericytoma

Undifferentiated Pleomorphic Sarcoma

Synovial Sarcoma

Malignant Peripheral Nerve Sheath Tumor

Uterine Sarcoma

Peter Reichardt, MD

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

PURPOSE: Phase II trial to study the effectiveness of exatecan mesylate in treating patients who have advanced soft tissue sarcoma.

OBJECTIVES:

* Determine the anticancer activity of exatecan mesylate, in terms of objective response and duration of response, in patients with advanced soft tissue sarcoma.
* Determine the safety of this drug in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to histological diagnosis (leiomyosarcoma vs other histologies).

Patients receive exatecan mesylate IV over 30 minutes daily on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 weeks until disease progression. After disease progression, patients are followed every 12 weeks for survival.

PROJECTED ACCRUAL: A total of 32-50 patients (16-25 per stratum) will be accrued for this study.

Exatecan Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma

Exatecan As Second-Line Treatment In Advanced Adult Soft Tissue Sarcoma: A Phase II - Study Of The EORTC Soft Tissue And Bone Sarcoma Group

European Organisation for Research and Treatment of Cancer - EORTC

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Neoplasm Metastasis

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Gastrointestinal Agents

Pancrelipase

Pancreatin

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

PURPOSE: Phase II trial to study the effectiveness of DX-8951f in treating patients who have metastatic cancer of the pancreas that has not been previously treated or that has not responded to previous chemotherapy.

OBJECTIVES: I. Determine the objective response rate in patients with metastatic carcinoma of the exocrine pancreas treated with DX-8951f. II. Determine the time to tumor progression in patients receiving this drug. III. Determine the survival at 6 and 12 months of patients receiving this drug. IV. Evaluate the quantitative and qualitative toxicities of this regimen in this patient population. V. Evaluate the pharmacokinetics of this drug in this patient population.

OUTLINE: Patients receive DX-8951f IV over 30 minutes daily for 5 days. Courses repeat every 21 days. Treatment continues in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months until death.

PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study.

DX-8951f in Treating Patients With Metastatic Cancer of the Pancreas

A Phase II Study of Intravenous DX-8951f Administered Daily for Five Days Every Three Weeks to Patients With Metastatic Carcinoma of the Pancreas

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Fallopian Tube Neoplasms

Adnexal Diseases

Fallopian Tube Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Topotecan

Taxane

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

PURPOSE: Phase II trial to study the effectiveness of DX-8951f in treating patients who have recurrent, metastatic, or unresectable ovarian, fallopian tube, or peritoneal cancer.

OBJECTIVES: I. Determine the antitumor activity of DX-8951f in patients with recurrent, metastatic, or unresectable ovarian, tubal, or peritoneal carcinoma that is refractory to platinum, taxane, and topotecan. II. Evaluate the quantitative and qualitative toxic effects of this regimen in these patients. III. Evaluate the pharmacokinetics of this regimen in these patients.

OUTLINE: Patients are stratified by prior chemotherapy (minimally pretreated vs heavily pretreated). Patients receive intravenous DX-8951f over 30 minutes daily for 5 days. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until death.

PROJECTED ACCRUAL: Approximately 37 patients will be accrued for this study.

Chemotherapy in Treating Patients With Recurrent, Metastatic, or Unresectable Ovarian, Fallopian Tube, or Peritoneal Cancer

A Phase II Study of Intravenous DX-8951f Administered Daily for Five Days Every Three Weeks to Patients With Advanced Ovarian, Tubal, or Peritoneal Cancer Refractory to Platinum, Taxane and Topotecan

Prostatic Neoplasms

Genital Neoplasms, Male

Genital Diseases, Male

Prostatic Diseases

Male Urogenital Diseases

Hormones

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

PURPOSE: Phase II trial to study the effectiveness of DX-8951f in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.

OBJECTIVES: I. Determine the antitumor activity of DX-8951f as measured by PSA response in patients with hormone refractory prostate cancer. II. Determine the antitumor activity of this drug in the subpopulation of these patients with measurable disease. III. Evaluate the quantitative and qualitative toxicities of this drug in these patients. IV. Evaluate the pharmacokinetics of this drug in these patients.

OUTLINE: This is a multicenter study. Patients receive DX-8951f IV over 30 minutes daily for 5 days. Courses repeat every 21 days. Treatment continues in the absence of unacceptable toxicity or disease progression. Patients with no evidence of PSA decrease by the start of course 3 receive no further treatment. Patients are followed every 3 months until death.

PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study.

Chemotherapy in Treating Patients With Prostate Cancer

A Phase II Study of Intravenous DX-8951f Administered Daily for Five Days Every Three Weeks to Patients With Hormone-Refractory Prostate Cancer

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Nick Thatcher, PhD, FRCP

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

PURPOSE: Phase II trial to study the effectiveness of DX-8951f in treating patients who have previously untreated stage IIIB or stage IV non-small cell lung cancer.

OBJECTIVES: I. Determine the antitumor activity of DX-8951f in previously untreated patients with stage IIIB or IV non-small cell lung cancer. II. Evaluate the quantitative and qualitative toxic effects of this regimen in these patients. III. Evaluate the pharmacokinetics of this regimen in these patients. IV. Assess the time to progression and survival status of these patients.

OUTLINE: This is a multicenter study. Patients receive DX-8951f IV over 30 minutes daily for 5 days. Treatment repeats every 3 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for survival.

PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study.

DX-8951f in Treating Previously Untreated Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer

A Phase II Study of Intravenous DX-8951f Administered Daily for Five Days Every Three Weeks to Patients With Stage IIIb or Stage IV Non-Small Cell Lung Cancer as First Line Therapy

Daiichi Pharmaceuticals

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

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

PURPOSE: Phase II trial to study the effectiveness of DX-8951f in treating women who have metastatic breast cancer that has not responded to previous therapy.

OBJECTIVES: I. Determine the antitumor activity of DX-8951f in women with metastatic adenocarcinoma of the breast who have failed prior therapy with an anthracycline and a taxane. II. Evaluate the quantitative and qualitative toxicities of this drug in these patients. III. Evaluate the pharmacokinetics of this drug in these patients.

OUTLINE: Patients receive DX-8951f IV over 30 minutes daily for 5 days. Courses repeat every 21 days. Treatment continues in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months until death.

PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
DX-8951f in Treating Women Who Have Advanced or Recurrent Cancer of the Cervix	NCT00004866	Cervical Cancer	exatecan mesyla...	18 Years -	Daiichi Sankyo
DX-8951f in Treating Patients With Biliary Cancer	NCT00005938	Extrahepatic Bi... Gallbladder Can... Liver Cancer	exatecan mesyla...	16 Years -	Daiichi Sankyo
DX-8951f in Treating Patients With Metastatic Stomach Cancer	NCT00017212	Esophageal Canc... Gastric Cancer	exatecan mesyla...	18 Years -	Daiichi Sankyo
Chemotherapy in Treating Patients Who Have Hematologic Cancer	NCT00004047	Leukemia Myelodysplastic...	exatecan mesyla...	-	Daiichi Sankyo
Exatecan Mesylate in Treating Children With Relapsed or Refractory Rhabdomyosarcoma	NCT00055939	Sarcoma	exatecan mesyla...	-	Daiichi Sankyo
Exatecan Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma	NCT00041236	Sarcoma	exatecan mesyla...	15 Years - 75 Years	European Organisation for Research and Treatment of Cancer - EORTC
DX-8951f in Treating Patients With Metastatic Cancer of the Pancreas	NCT00003951	Pancreatic Canc...	exatecan mesyla...	18 Years -	Daiichi Sankyo
DX-8951f in Treating Patients With Biliary Cancer	NCT00005938	Extrahepatic Bi... Gallbladder Can... Liver Cancer	exatecan mesyla...	16 Years -	Daiichi Sankyo
DX-8951f in Treating Patients With Biliary Cancer	NCT00005938	Extrahepatic Bi... Gallbladder Can... Liver Cancer	exatecan mesyla...	16 Years -	Daiichi Sankyo
Exatecan Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma	NCT00041236	Sarcoma	exatecan mesyla...	15 Years - 75 Years	European Organisation for Research and Treatment of Cancer - EORTC
Chemotherapy in Treating Patients With Recurrent, Metastatic, or Unresectable Ovarian, Fallopian Tube, or Peritoneal Cancer	NCT00004060	Fallopian Tube ... Ovarian Cancer Primary Periton...	exatecan mesyla...	18 Years -	Daiichi Sankyo
Chemotherapy in Treating Patients With Prostate Cancer	NCT00004045	Prostate Cancer	exatecan mesyla...	18 Years -	Daiichi Sankyo
DX-8951f in Treating Previously Untreated Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer	NCT00005091	Lung Cancer	exatecan mesyla...	18 Years -	National Cancer Institute (NCI)
Chemotherapy in Treating Women With Metastatic Breast Cancer	NCT00004046	Breast Cancer	exatecan mesyla...	18 Years -	Daiichi Sankyo
Exatecan Mesylate in Treating Patients With Advanced Solid Tumors and Kidney Dysfunction	NCT00045318	Unspecified Adu...	exatecan mesyla...	18 Years -	National Cancer Institute (NCI)

Spots Global Cancer Trial Database for exatecan mesylate