Completed PHASE1 NCT00031681

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)

A Phase I Study of UCN-01 in Combination With Irinotecan in Resistant Solid Tumor Malignancies (Part I) and in Triple Negative (ER-Negative, PgR-Negative, HER-2 Not-Amplified) Recurrent Breast Cancers (Part II)

Sponsor: National Cancer Institute (NCI)

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 7-hydroxystaurosporine diagnostic laboratory biomarker analysis irinotecan hydrochloride

Updated 6 times since 2017 Last updated: Sep 27, 2013 Started: Dec 31, 2001 Primary completion: Jan 31, 2011

A PHASE1 clinical study on Advanced Adult Primary Liver Cancer and Carcinoma of the Appendix, this trial is completed. The trial is conducted by National Cancer Institute (NCI) and has accumulated 6 data snapshots since 2001. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

Change History

6 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1
Jan 2021 — Jul 2024 [monthly]

Completed PHASE1
Jun 2018 — Jan 2021 [monthly]

Completed PHASE1
Feb 2017 — Jun 2018 [monthly]

Completed PHASE1

▶ Show 1 earlier version

Jan 2017 — Feb 2017 [monthly]

Completed PHASE1

First recorded

Dec 2001

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

National Cancer Institute (NCI)
Washington University Siteman Cancer Center

Data source: National Cancer Institute (NCI)

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Charlottesville, United States