|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | University of Virginia |
|---|---|
| Collaborators: |
National Cancer Institute (NCI) Washington University Siteman Cancer Center |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00031681 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving UCN-01 together with irinotecan may help kill more cancer cells by making tumor cells more sensitive to the drug.
PURPOSE: This phase I trial is studying the side effects and best dose of giving UCN-01 together with irinotecan 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).
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer |
Drug: 7-hydroxystaurosporine Drug: irinotecan hydrochloride Other: laboratory biomarker analysis |
Phase I |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | 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) |
| Estimated Enrollment: | 41 |
| Study Start Date: | December 2001 |
| Estimated Primary Completion Date: | July 2002 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE:
This is a dose-escalation study.
Patients receive irinotecan IV over 90 minutes on days 1, 8, 15, and 22 and UCN-01 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 and UCN-01 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.
Patients receive irinotecan IV and UCN-01 IV as in part I at the MTD and undergo blood sample collection.
PROJECTED ACCRUAL: A total of 41 patients (21 part I [closed to accrual as of 6/8/2007] and 20 part II) will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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:
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
Part II
Histologically confirmed (either primary or the recurrent site) locally recurrent or metastatic breast cancer not amendable to surgery
Measurable disease
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Missouri | |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | |
| Saint Louis, Missouri, United States, 63110 | |
| United States, Virginia | |
| University of Virginia Cancer Center | |
| Charlottesville, Virginia, United States, 22908 | |
| Study Chair: | Paula M. Fracasso, MD, PhD | University of Virginia |
| Principal Investigator: | Cynthia X. Ma, MD, PhD | Washington University Siteman Cancer Center |
More Information
| ClinicalTrials.gov Identifier: | NCT00031681 History of Changes |
| Other Study ID Numbers: | CDR0000069215, UVACC-SCC-0102, WUSM-SCC-0102, NCI-5582 |
| Study First Received: | March 8, 2002 |
| Last Updated: | February 22, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
stage IV colon cancer stage IV breast cancer recurrent breast cancer stage IV gastric cancer recurrent gastric cancer recurrent non-small cell lung cancer recurrent pancreatic cancer stage IV rectal cancer recurrent colon cancer recurrent rectal cancer stage IV anal cancer recurrent anal cancer stage IV esophageal cancer recurrent esophageal cancer recurrent cervical cancer |
stage IVB cervical cancer stage IVA cervical cancer stage IV ovarian epithelial cancer recurrent ovarian epithelial cancer extensive stage small cell lung cancer recurrent small cell lung cancer metastatic gastrointestinal carcinoid tumor recurrent gastrointestinal carcinoid tumor advanced adult primary liver cancer recurrent adult primary liver cancer stage IV endometrial carcinoma recurrent endometrial carcinoma small intestine adenocarcinoma small intestine lymphoma small intestine leiomyosarcoma |
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases 7-hydroxystaurosporine Irinotecan Camptothecin Staurosporine Protein Kinase Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antineoplastic Agents, Phytogenic Radiation-Sensitizing Agents Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors |