# 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)

> **NCT00031681** · PHASE1 · COMPLETED · sponsor: **National Cancer Institute (NCI)** · enrollment: 41 (actual)

## Conditions studied

- 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
- **DRUG:** irinotecan hydrochloride
- **OTHER:** diagnostic laboratory biomarker analysis

## Key facts

- **NCT ID:** NCT00031681
- **Lead sponsor:** National Cancer Institute (NCI)
- **Sponsor class:** NIH
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2001-12
- **Primary completion:** 2011-01
- **Final completion:** —
- **Target enrollment:** 41 (ACTUAL)
- **Last updated:** 2013-09-30

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00031681

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration 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)". Retrieved via AI Analytics 2026-06-10 from https://api.ai-analytics.org/clinical/NCT00031681. Licensed CC0.

---

*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*