- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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)
Study Overview
Status
Conditions
- Recurrent Prostate Cancer
- Unspecified Adult Solid Tumor, Protocol Specific
- Small Intestine Lymphoma
- Recurrent Pancreatic Cancer
- Stage IV Pancreatic Cancer
- Recurrent Endometrial Carcinoma
- Stage IV Breast Cancer
- Stage IV Ovarian Epithelial Cancer
- Stage IV Ovarian Germ Cell Tumor
- Triple-negative Breast Cancer
- Gastrointestinal Stromal Tumor
- Metastatic Gastrointestinal Carcinoid Tumor
- Recurrent Gastrointestinal Carcinoid Tumor
- Stage IV Prostate Cancer
- Extensive Stage Small Cell Lung Cancer
- Recurrent Small Cell Lung Cancer
- Ovarian Sarcoma
- Recurrent Breast Cancer
- Estrogen Receptor-negative Breast Cancer
- Progesterone Receptor-negative Breast Cancer
- Recurrent Ovarian Epithelial Cancer
- HER2-negative Breast Cancer
- Stage IV Colon Cancer
- Stage IV Rectal Cancer
- Stage IV Gastric Cancer
- Stage IV Endometrial Carcinoma
- Recurrent Colon Cancer
- Recurrent Rectal Cancer
- Recurrent Gastric Cancer
- Recurrent Metastatic Squamous Neck Cancer With Occult Primary
- Recurrent Salivary Gland 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 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
- Recurrent Non-small Cell Lung Cancer
- Stage IV Non-small Cell Lung Cancer
- Advanced Adult Primary Liver Cancer
- Carcinoma of the Appendix
- Ovarian Stromal Cancer
- Recurrent Adult Primary Liver Cancer
- Recurrent Extrahepatic Bile Duct Cancer
- Recurrent Gallbladder Cancer
- Recurrent Ovarian Germ Cell Tumor
- Recurrent Small Intestine Cancer
- Small Intestine Adenocarcinoma
- Small Intestine Leiomyosarcoma
- Unresectable Extrahepatic Bile Duct Cancer
- Unresectable Gallbladder Cancer
- Recurrent Adenoid Cystic Carcinoma of the Oral Cavity
- Recurrent Basal Cell Carcinoma of the Lip
- Recurrent Lymphoepithelioma of the Nasopharynx
- Recurrent Lymphoepithelioma of the Oropharynx
- Recurrent Mucoepidermoid Carcinoma of the Oral Cavity
- Recurrent Squamous Cell Carcinoma of the Nasopharynx
- Stage IV Adenoid Cystic Carcinoma of the Oral Cavity
- Stage IV Basal Cell Carcinoma of the Lip
- Stage IV Lymphoepithelioma of the Nasopharynx
- Stage IV Lymphoepithelioma of the Oropharynx
- Stage IV Mucoepidermoid Carcinoma of the Oral Cavity
- 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 Verrucous Carcinoma of the Larynx
- Stage IV Verrucous Carcinoma of the Oral Cavity
- Recurrent Esophageal Cancer
- Stage IV Esophageal Cancer
- Untreated Metastatic Squamous Neck Cancer With Occult Primary
- Recurrent Cervical Cancer
- Stage IVA Cervical Cancer
- Stage IVB Cervical Cancer
- Recurrent Anal Cancer
- Stage IV Anal Cancer
- Stage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
- Recurrent Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity
- Recurrent Inverted Papilloma of the Paranasal Sinus and Nasal Cavity
- Recurrent Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity
- Stage IV Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity
- Stage IV Inverted Papilloma of the Paranasal Sinus and Nasal Cavity
- Stage IV Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity
- Recurrent Borderline Ovarian Surface Epithelial-stromal Tumor
- Stage IV Borderline Ovarian Surface Epithelial-stromal Tumor
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose of UCN-01 (7-hydroxystaurosporine) and irinotecan (irinotecan hydrochloride) in patients with resistant solid tumors. (Part I [closed to accrual as of 6/8/2007]) II. Determine the dose-limiting toxicity of this regimen in these patients. (Part I [closed to accrual as of 6/8/2007]) III. Determine the types of toxic effects of this regimen in these patients. (Part I [closed to accrual as of 6/8/2007]) IV. Determine the anti-tumor activity in terms of overall response rate (partial response [PR] and complete response [CR]), clinical benefit rate (PR, CR, and stable disease), and time to disease progression in patients with estrogen receptor-negative, progesterone receptor-negative, and HER-2 not amplified (triple negative) locally recurrent or metastatic breast cancer treated with this regimen. (Part II) V. Determine the side effect profile of this regimen in patients with triple negative recurrent breast cancer. (Part II)
SECONDARY OBJECTIVES:
I. Determine any anti-tumor activity of this regimen in these patients. (Part I [closed to accrual as of 6/8/2007]) II. Determine the pharmacokinetics of this regimen in these patients. (Part I [closed to accrual as of 6/8/2007]) III. Determine the activity of the serum α-acid glycoprotein and correlate this level with free UCN-01 concentrations. (Part I [closed to accrual as of 6/8/2007]) IV. Determine the in vivo mechanisms of UCN-01 activity in these patients.
OUTLINE: This is a dose-escalation study.
PART I: Patients receive irinotecan hydrochloride intravenously (IV) over 90 minutes on days 1, 8, 15, and 22 and 7-hydroxystaurosporine IV over 3 hours on days 2 and 23. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of irinotecan hydrochloride and 7-hydroxystaurosporine 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. Blood samples are collected periodically during study treatment.
PART II: (treatment of triple negative recurrent breast cancer): Patients receive irinotecan hydrochloride IV and 7-hydroxystaurosporine IV as in part I at the MTD and undergo blood sample collection.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Virginia
-
Charlottesville, Virginia, United States, 22908
- University of Virginia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Part I (closed to accrual as of 6/8/2007)
Histologically confirmed solid tumor that is metastatic or unresectable for which standard curative measures do not exist or are no longer effective, including the following:
- Gastrointestinal tract cancer
- Lung cancer
- Breast cancer
- Ovarian cancer
- Endometrial cancer
- Cervical cancer
- Prostate cancer
- Head and neck cancer
Patients with or without measurable or evaluable disease allowed
Measurable disease, defined as ≥ 1 unidimensionally measurable lesion > 20 mm by conventional techniques or ≥ 10 mm with spiral CT scan
- Tumor markers allowed for evaluable disease
- Positive bone scan, osteoblastic metastases, and pleural or peritoneal effusions are not considered measurable or evaluable disease
- No known brain metastases
Part II
Histologically confirmed (either primary or the recurrent site) locally recurrent or metastatic breast cancer not amendable to surgery
Measurable disease
- For skin lesions, documentation by color photography and estimation of lesion size with a ruler are required
- Must have undergone prior therapy with an anthracycline and a taxane either in the adjuvant or metastatic setting
- CNS metastasis allowed provided stable disease (i.e., no evidence of local progression) ≥ 3 months after local therapy
Hormone receptor status:
- Estrogen receptor negative
- Progesterone receptor negative
- HER-2 not amplified by fluorescence in situ hybridization
- Performance status - ECOG 0-2
- Performance status - Karnofsky 60-100%
- More than 12 weeks
- WBC at least 3,000/mm^3
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin ≥ 10 g/dL
- Bilirubin normal
- AST/ALT no greater than 3 times upper limit of normal (ULN)
- No Gilbert's disease
- No chronic unconjugated hyperbilirubinemia
- Creatinine no greater than 1.5 times ULN
- Creatinine clearance at least 60 mL/min
- No symptomatic cardiac dysfunction
- No symptomatic pulmonary dysfunction
- Oxygen saturation at least 90% by pulse oximetry on room air at rest and after walking 6 minutes
- No insulin-dependent diabetes mellitus
- No other uncontrolled concurrent illness
- No active or ongoing infection
- No psychiatric illness or social situation that would preclude study entry
- No prior allergic reactions attributed to compounds of similar chemical or biological composition to UCN-01 or irinotecan
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No concurrent granulocyte colony-stimulating factors (filgrastim [G-CSF] or sargramostim [GM-CSF]) during the first course of study
- See Disease Characteristics (Part II)
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- Prior irinotecan allowed
- Less than 4 prior chemotherapy regimens in the adjuvant and/or metastatic setting (Part II)
- More than 4 weeks since prior radiotherapy and recovered
- Concurrent warfarin allowed
- Concurrent subcutaneous heparin allowed
- No other concurrent investigational agents
- No concurrent anticonvulsants (e.g., carbamazepine, phenobarbital, or phenytoin)
- No concurrent combination antiretroviral therapy for HIV-positive patients
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Treatment (combination chemotherapy)
PART I: Patients receive irinotecan hydrochloride IV over 90 minutes on days 1, 8, 15, and 22 and 7-hydroxystaurosporine IV over 3 hours on days 2 and 23. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of irinotecan hydrochloride and 7-hydroxystaurosporine until the 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. Blood samples are collected periodically during study treatment. PART II: (treatment of triple negative recurrent breast cancer): Patients receive irinotecan hydrochloride IV and 7-hydroxystaurosporine IV as in part I at the MTD and undergo blood sample collection. |
Given IV
Other Names:
Correlative studies
Given IV
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MTD of irinotecan hydrochloride in combination with 7-hydroxystaurosporine in patients with resistant solid tumor malignancies (Part I)
Time Frame: Part I
|
Defined as the highest dose given to at least 6 patients in which =< 1 out of 6 experience dose limiting toxicity (DLT).
|
Part I
|
DLT of irinotecan hydrochloride in combination with 7-hydroxystaurosporine in patients with resistant solid tumor malignancies (Part I)
Time Frame: Part I
|
Part I
|
|
Toxicities associated with irinotecan hydrochloride in combination with 7-hydroxystaurosporine in patients with resistant solid tumor malignancies (Part I)
Time Frame: Continuously over study treatment
|
Graded using the Cancer Therapy Evaluation Program (CTEP) Active Version of the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).
|
Continuously over study treatment
|
Anti-tumor activity of 7-hydroxystaurosporine in combination with irinotecan hydrochloride in ER-negative, PgR-negative, HER-2 not-amplified (triple negative) recurrent breast cancer (Part II)
Time Frame: Every 6 weeks
|
Including overall response rate (partial response [PR] +complete response [CR]), clinical benefit rate (PR+CR+stable disease [SD]), and time to disease progression.
95% confidence interval will be calculated.
Evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
|
Every 6 weeks
|
Side effect profile of 7-hydroxystaurosporine in combination with irinotecan hydrochloride in triple negative recurrent breast cancer (Part II)
Time Frame: Continuously over study treatment
|
95 % confidence interval will be calculated.
|
Continuously over study treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anti-tumor activity of the combination of irinotecan hydrochloride and 7-hydroxystaurosporine in treatment of patients with resistant solid tumor malignancies
Time Frame: Every 6 weeks
|
Evaluated by the RECIST criteria.
|
Every 6 weeks
|
Pharmacokinetics of irinotecan hydrochloride and 7-hydroxystaurosporine when administered in combination
Time Frame: Weekly during the first 4 weeks of course 1
|
Using the high-performance liquid chromatography (HPLC) assays.
|
Weekly during the first 4 weeks of course 1
|
Serum alpha-acid glycoprotein and correlate this level with free 7-hydroxystaurosporine concentrations
Time Frame: Weekly during the first 4 weeks of course 1
|
Weekly during the first 4 weeks of course 1
|
|
In vivo mechanistic basis for 7-hydroxystaurosporine activity
Time Frame: Weekly during the first 4 weeks of course 1
|
Explored by subgroup analysis (responders versus non-responders) on pharmacodynamic measures.
|
Weekly during the first 4 weeks of course 1
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Paula Fracasso, University of Virginia
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Nervous System Diseases
- Skin Diseases
- Respiratory Tract Diseases
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Lung Diseases
- Urogenital Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Endocrine System Diseases
- Disease Attributes
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Endocrine Gland Neoplasms
- Genital Neoplasms, Male
- Breast Diseases
- Liver Diseases
- Prostatic Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Mouth Diseases
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Nerve Tissue
- Colonic Diseases
- Intestinal Diseases
- Rectal Diseases
- Neoplastic Processes
- Esophageal Diseases
- Paranasal Sinus Diseases
- Nose Diseases
- Colorectal Neoplasms
- Cranial Nerve Diseases
- Gallbladder Diseases
- Biliary Tract Diseases
- Pancreatic Diseases
- Neoplasms, Connective Tissue
- Neuroendocrine Tumors
- Sarcoma
- Neoplasm Metastasis
- Neuroectodermal Tumors, Primitive
- Neoplasms, Squamous Cell
- Neoplasms, Cystic, Mucinous, and Serous
- Neoplasms, Muscle Tissue
- Nasopharyngeal Neoplasms
- Neoplasms, Basal Cell
- Bile Duct Diseases
- Neuroectodermal Tumors, Primitive, Peripheral
- Salivary Gland Diseases
- Anus Diseases
- Mouth Neoplasms
- Biliary Tract Neoplasms
- Olfactory Nerve Diseases
- Neoplasms, Fibrous Tissue
- Neoplasms, Fibroepithelial
- Nose Neoplasms
- Neuroblastoma
- Neoplasms
- Uterine Cervical Neoplasms
- Stomach Neoplasms
- Neoplasms, Germ Cell and Embryonal
- Breast Neoplasms
- Head and Neck Neoplasms
- Prostatic Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Carcinoma
- Nasopharyngeal Carcinoma
- Recurrence
- Ovarian Neoplasms
- Rectal Neoplasms
- Endometrial Neoplasms
- Small Cell Lung Carcinoma
- Carcinoma, Adenoid Cystic
- Pancreatic Neoplasms
- Gastrointestinal Stromal Tumors
- Gastrointestinal Neoplasms
- Carcinoma, Ovarian Epithelial
- Carcinoma, Squamous Cell
- Squamous Cell Carcinoma of Head and Neck
- Cholangiocarcinoma
- Liver Neoplasms
- Triple Negative Breast Neoplasms
- Esophageal Neoplasms
- Granuloma
- Colonic Neoplasms
- Leiomyosarcoma
- Intestinal Neoplasms
- Anus Neoplasms
- Neoplasms, Unknown Primary
- Oropharyngeal Neoplasms
- Salivary Gland Neoplasms
- Carcinoid Tumor
- Gallbladder Neoplasms
- Malignant Carcinoid Syndrome
- Esthesioneuroblastoma, Olfactory
- Carcinoma, Basal Cell
- Papilloma
- Laryngeal Neoplasms
- Brenner Tumor
- Laryngeal Diseases
- Bile Duct Neoplasms
- Carcinoma, Verrucous
- Carcinoma, Mucoepidermoid
- Mucoepidermoid Tumor
- Germinoma
- Paranasal Sinus Neoplasms
- Papilloma, Inverted
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase Inhibitors
- Protein Kinase Inhibitors
- Topoisomerase I Inhibitors
- Irinotecan
- 7-hydroxystaurosporine
Other Study ID Numbers
- NCI-2009-00019 (REGISTRY: CTRP (Clinical Trial Reporting Program))
- 5582 (OTHER: CTEP)
- P30CA044579 (U.S. NIH Grant/Contract)
- NCI-5582
- WUSM-SCC-0102
- CDR0000069215
- UVACC-SCC-0102
- SCC 01-02 (OTHER: University of Virginia)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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