Clinical trial · Interventional
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (88)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Adult Primary Liver Cancer | — | UNRESOLVED | — |
| Carcinoma of the Appendix | Appendix Carcinoma | ALIAS | 0.90 |
| Estrogen Receptor-negative Breast Cancer | — | UNRESOLVED | — |
| Extensive Stage Small Cell Lung Cancer | Lung Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Gastrointestinal Stromal Tumor | Gastrointestinal Stromal Tumor | ONTOLOGY_EXACT | 0.98 |
| HER2-negative Breast Cancer | — | UNRESOLVED | — |
| Metastatic Gastrointestinal Carcinoid Tumor | Digestive System Neuroendocrine Tumor G1 | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 7-hydroxystaurosporine | Drug | — | UNRESOLVED |
| diagnostic laboratory biomarker analysis | Other | — | UNRESOLVED |
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (combination chemotherapy)
- description
- 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.
- interventionNames
- Drug: 7-hydroxystaurosporine
- Drug: irinotecan hydrochloride
- Other: diagnostic laboratory biomarker analysis
Primary outcomes (5)
- measure
- MTD of irinotecan hydrochloride in combination with 7-hydroxystaurosporine in patients with resistant solid tumor malignancies (Part I)
- timeFrame
- Part I
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 patientsReferences
Publications (0)
Data not yet available