Overview

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)

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Cancer Institute (NCI)
Collaborator:
Washington University Siteman Cancer Center
Treatments:
7-hydroxystaurosporine
Camptothecin
Irinotecan
Staurosporine
Criteria
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