7-Hydroxystaurosporine and Irinotecan Hydrochloride in Treating Patients With Metastatic or Unresectable Solid Tumors or Triple Negative Breast Cancer (Currently Accruing Only Triple-negative Breast Cancer Patients Since 6/8/2007)

Summary

This phase I trial is studying the side effects and best dose of giving 7-hydroxystaurosporine together with irinotecan hydrochloride in treating patients with metastatic or unresectable solid tumors, including triple-negative breast cancer (currently enrolling only patients with triple-negative breast cancer since 6/8/2007). Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving 7-hydroxystaurosporine together with irinotecan hydrochloride may help kill more cancer cells by making tumor cells more sensitive to the drug.

Conditions

• Advanced Adult Primary Liver Cancer
• Carcinoma of the Appendix
• Estrogen Receptor-negative Breast Cancer
• Extensive Stage Small Cell Lung Cancer
• Gastrointestinal Stromal Tumor
• HER2-negative Breast Cancer
• Metastatic Gastrointestinal Carcinoid Tumor
• Ovarian Sarcoma
• Ovarian Stromal Cancer
• Progesterone Receptor-negative Breast Cancer
• Recurrent Adenoid Cystic Carcinoma of the Oral Cavity
• Recurrent Adult Primary Liver Cancer
• Recurrent Anal Cancer
• Recurrent Basal Cell Carcinoma of the Lip
• Recurrent Borderline Ovarian Surface Epithelial-stromal Tumor
• Recurrent Breast Cancer
• Recurrent Cervical Cancer
• Recurrent Colon Cancer
• Recurrent Endometrial Carcinoma
• Recurrent Esophageal Cancer
• Recurrent Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity
• Recurrent Extrahepatic Bile Duct Cancer
• Recurrent Gallbladder Cancer
• Recurrent Gastric Cancer
• Recurrent Gastrointestinal Carcinoid Tumor
• Recurrent Inverted Papilloma of the Paranasal Sinus and Nasal Cavity
• Recurrent Lymphoepithelioma of the Nasopharynx
• Recurrent Lymphoepithelioma of the Oropharynx
• Recurrent Metastatic Squamous Neck Cancer With Occult Primary
• Recurrent Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity
• Recurrent Mucoepidermoid Carcinoma of the Oral Cavity
• Recurrent Non-small Cell Lung Cancer
• Recurrent Ovarian Epithelial Cancer
• Recurrent Ovarian Germ Cell Tumor
• Recurrent Pancreatic Cancer
• Recurrent Prostate Cancer
• Recurrent Rectal Cancer
• Recurrent Salivary Gland Cancer
• Recurrent Small Cell Lung Cancer
• Recurrent Small Intestine Cancer
• Recurrent Squamous Cell Carcinoma of the Hypopharynx
• Recurrent Squamous Cell Carcinoma of the Larynx
• Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity
• Recurrent Squamous Cell Carcinoma of the Nasopharynx
• Recurrent Squamous Cell Carcinoma of the Oropharynx
• Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
• Recurrent Verrucous Carcinoma of the Larynx
• Recurrent Verrucous Carcinoma of the Oral Cavity
• Small Intestine Adenocarcinoma
• Small Intestine Leiomyosarcoma
• Small Intestine Lymphoma
• Stage IV Adenoid Cystic Carcinoma of the Oral Cavity
• Stage IV Anal Cancer
• Stage IV Basal Cell Carcinoma of the Lip
• Stage IV Borderline Ovarian Surface Epithelial-stromal Tumor
• Stage IV Breast Cancer
• Stage IV Colon Cancer
• Stage IV Endometrial Carcinoma
• Stage IV Esophageal Cancer
• Stage IV Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity
• Stage IV Gastric Cancer
• Stage IV Inverted Papilloma of the Paranasal Sinus and Nasal Cavity
• Stage IV Lymphoepithelioma of the Nasopharynx
• Stage IV Lymphoepithelioma of the Oropharynx
• Stage IV Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity
• Stage IV Mucoepidermoid Carcinoma of the Oral Cavity
• Stage IV Non-small Cell Lung Cancer
• Stage IV Ovarian Epithelial Cancer
• Stage IV Ovarian Germ Cell Tumor
• Stage IV Pancreatic Cancer
• Stage IV Prostate Cancer
• Stage IV Rectal Cancer
• Stage IV Salivary Gland Cancer
• Stage IV Squamous Cell Carcinoma of the Hypopharynx
• Stage IV Squamous Cell Carcinoma of the Larynx
• Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity
• Stage IV Squamous Cell Carcinoma of the Nasopharynx
• Stage IV Squamous Cell Carcinoma of the Oropharynx
• Stage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
• Stage IV Verrucous Carcinoma of the Larynx
• Stage IV Verrucous Carcinoma of the Oral Cavity
• Stage IVA Cervical Cancer
• Stage IVB Cervical Cancer
• Triple-negative Breast Cancer
• Unresectable Extrahepatic Bile Duct Cancer
• Unresectable Gallbladder Cancer
• Unspecified Adult Solid Tumor, Protocol Specific
• Untreated Metastatic Squamous Neck Cancer With Occult Primary

Interventions

DRUG

7-hydroxystaurosporine

Given IV

DRUG

irinotecan hydrochloride

Given IV

OTHER

diagnostic laboratory biomarker analysis

Correlative studies

Sponsors & Collaborators

• Washington University Siteman Cancer Center

  collaborator OTHER

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Paula Fracasso · University of Virginia

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2001-12-31

Primary Completion

2011-01-31

Countries

• United States

Study Locations