CCI-779 and EKB-569 in Treating Patients With Advanced Solid Tumors
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Purpose
This phase I trial is studying the side effects, best way to give, and best dose of CCI-779 and EKB-569 in treating patients with advanced solid tumors. Drugs used in chemotherapy, such as CCI-779, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. EKB-569 may stop the growth of tumor cells by blocking some of the enzymes needed for their growth. Giving CCI-779 together with EKB-569 may kill more tumor cells.
| Condition | Intervention | Phase |
|---|---|---|
|
Unspecified Adult Solid Tumor, Protocol Specific |
Drug: pelitinib Drug: temsirolimus |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1 Trial of CCI-779 in Combination With EKB-569, an EGFR Inhibitor, in Patients With Solid Tumors |
- Maximum tolerated dose (MTD) defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least one-third of patients [ Time Frame: Up to 28 days ] [ Designated as safety issue: Yes ]
- Number and severity of all adverse events per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0 [ Time Frame: Up to 30 days after last dose of study treatment ] [ Designated as safety issue: Yes ]Frequency distributions, graphical techniques and other descriptive measures will form the basis of these analyses.
- Best response according to the Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Time from the start of the treatment until disease progression/recurrence, assessed up to 3 years ] [ Designated as safety issue: No ]
- Time until any treatment related toxicity [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
- Time until treatment related grade 3+ toxicity [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
- Time until hematologic nadirs (white blood cells [WBC], absolute neutrophil count [ANC], platelets) [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
- Time to progression [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
- Time to treatment failure [ Time Frame: Time from registration to documentation of progression, unacceptable toxicity, or refusal to continue participation by the patient, assessed up to 3 years ] [ Designated as safety issue: No ]
| Enrollment: | 42 |
| Study Start Date: | October 2004 |
| Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Patients receive oral EKB-569 on days 1-28 and oral CCI-779 on days 1-7 and 15-21.
|
Drug: pelitinib
Other Name: EKB-569
Drug: temsirolimus
Given PO
Other Names:
|
Detailed Description:
OBJECTIVES:
I. Determine the maximum tolerated dose of the combination of CCI-779 and EKB-569 in patients with advanced solid tumors.
II. Determine the toxicity of this regimen in these patients. III. Determine the response rate in patients treated with this regimen.
OUTLINE: This is a dose-escalation study. Patients are assigned to 1 of 3 treatment groups.
Group I: Patients receive oral EKB-569 on days 1-28 and oral CCI-779 on days 1-7 and 15-21.
Cohorts of 3-6 patients receive escalating doses of EKB-569 and CCI-779 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.
Group II: Patients receive oral EKB-569 at the MTD on days 4-28 of course 1 and days 1-28 of all subsequent courses and CCI-779 at the MTD on days 1-3 and 15-17.
Group III: Patients receive EKB-569 at the MTD as in group I and oral CCI-779 at the MTD on days 7-9 and 19-21 of course 1 and days 1-3 and 15-17 of all subsequent courses.
In all groups, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 30-42 patients (18-30 for group I, 6 for group II, and 6 for group III) will be accrued for this study within 1.35-1.75 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically confirmed unresectable solid tumor for which there is no known standard therapy that is potentially curative or capable of extending life expectancy
- No CNS metastases
- Performance status - ECOG 0-2
- At least 12 weeks
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 10 g/dL
- Bilirubin normal
- AST ≤ 3 times upper limit of normal (ULN) (5 times ULN if liver involvement)
- Creatinine ≤ 1.5 times ULN
- No New York Heart Association class III or IV heart disease
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after study participation
- Fasting cholesterol < 350 mg/dL
- Fasting triglycerides < 400 mg/dL
- No uncontrolled infection
- No seizure disorder
- More than 4 weeks since prior immunotherapy
- More than 4 weeks since prior biologic therapy
- No concurrent immunotherapy
- No concurrent prophylactic colony-stimulating factor therapy
- More than 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered
- No other concurrent chemotherapy
- No concurrent oral contraceptives
- More than 4 weeks since prior radiotherapy
- No prior radiotherapy to > 30% of bone marrow
- No concurrent radiotherapy
- More than 7 days since prior CYP3A4 inducers
- No prior mTOR-targeting agents
- No prior epidermal growth factor receptor-targeting agents
- No concurrent antiretroviral therapy that induces or inhibits CYP3A4 for HIV-positive patients
- No other concurrent investigational agents
- No concurrent warfarin
Contacts and Locations More Information
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00098501 History of Changes |
| Other Study ID Numbers: | NCI-2012-01459, MC027C, NCI-6200, MAYO-MC027C, CDR0000398176, U01CA069912 |
| Study First Received: | December 7, 2004 |
| Last Updated: | June 3, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Neoplasms Sirolimus Everolimus Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
Antifungal Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on June 18, 2013