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