CCI-779 in Treating Patients With Soft Tissue Sarcoma or Gastrointestinal Stromal Tumor
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Purpose
This phase II trial is studying how well CCI-779 works in treating patients with soft tissue sarcoma or gastrointestinal stromal tumor. Drugs used in chemotherapy, such as CCI-779, work in different ways to stop tumor cells from dividing so they stop growing or die
| Condition | Intervention | Phase |
|---|---|---|
|
Gastrointestinal Stromal Tumor Recurrent Adult Soft Tissue Sarcoma Stage I Adult Soft Tissue Sarcoma Stage II Adult Soft Tissue Sarcoma Stage III Adult Soft Tissue Sarcoma Stage IV Adult Soft Tissue Sarcoma |
Drug: temsirolimus Other: laboratory biomarker analysis |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Trial of CCI-779 in Patients With Soft Tissue Sarcoma. |
- Proportion of confirmed tumor responses, defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart [ Time Frame: Up to 6 months (6 courses) ] [ Designated as safety issue: No ]
- Survival time [ Time Frame: Time from registration to death due to any cause, assessed up to 5 years ] [ Designated as safety issue: No ]The distribution of survival time will be estimated using the method of Kaplan-Meier.
- Time to disease progression [ Time Frame: Time from registration to documentation of disease progression, assessed up to 5 years ] [ Designated as safety issue: No ]The distribution of time to progression will be estimated using the method of Kaplan-Meier.
- Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
- Time to treatment failure [ Time Frame: Time from the date of randomization to the date at which the patient is removed from treatment due to progression, toxicity, or refusal, assessed up to 5 years ] [ Designated as safety issue: No ]
| Enrollment: | 55 |
| Study Start Date: | June 2004 |
| Primary Completion Date: | December 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment (temsirolimus)
Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses beyond CR.
|
Drug: temsirolimus
Given IV
Other Names:
Other: laboratory biomarker analysis
Optional correlative studies
|
Detailed Description:
PRIMARY OBJECTIVES:
I. To assess the antitumor activity of CCI-779 in this patient population.
SECONDARY OBJECTIVES:
I. To assess the following in patients with soft tissue sarcomas and following treatment with CCI-779: duration of response, time to progression, survival.
TERTIARY OBJECTIVES:
I. To describe and correlate the following with patient characteristics and outcome in this patient population and following treatment with CCI-779: relative levels of 4EBP1 to eIF4E, phospho 4EBP1, total and phospho ribosomal S6 on pretreatment tumor tissue, expression levels of EGFR, activated EGFR, Her2, c-Myc, phospho Akt, total Akt, phospho-mTOR and total mTOR on pretreatment tumor tissue, drug induced inhibition of p70S6 kinase activity, and phosphorylation of S6 in PBMC, relative levels of serum sirolimus in post-treatment samples.
OUTLINE:
Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses beyond CR.
Patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically or cytologic confirmed soft tissue sarcoma
- Measurable disease; for patients having only lesions measuring at least 1 cm to less than 2 cm, must use spiral CT imaging for both pre- and post-treatment tumor assessments
- Absolute neutrophil count (ANC) >= 1,500/μL
- Platelets (PLTS) >= 100,000/μL
- Hgb >= 10.0 g/dL
- Direct bilirubin =< 1.5 x ULN (upper limit normal)
- AST(SGOT) =< 2.5 x ULN or =< 5 x ULN* if liver metastases are present
- ALT(SGPT) =< 2.5 x ULN or =< 5 x ULN* if liver metastases are present
- Creatinine =< 1.5 x ULN, or if greater, creatinine clearance >= 50 mL/min/1.73 m^2
- Baseline glucose levels
- Fasting serum cholesterol =< 350 mg/dL (9.0 mmol/L)
- Fasting triglycerides =< 400 mg/dL (4.56 mmol/L)
- ECOG Performance Status (PS) 0, 1 or 2
- Life expectancy >= 12 weeks
- Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent
Exclusion Criteria:
Any of the following as this regimen may be harmful to a developing fetus or nursing child:
- Pregnant women
- Breast-feeding women
- Men or women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception ( diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.)
Any of the following:
- Nitrosoureas or mitomycin =< 6 weeks prior to study entry
- Other chemotherapy =< 4 weeks prior to study entry
- Radiotherapy =< 4 weeks prior to study entry
- Concurrent use of any other investigation agent
- Adverse events due to agents administered =< 4 weeks prior to study entry
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to CCI-779
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, diabetes, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Known HIV-positive patients receiving combination anti-retroviral therapy
Prior chemotherapy for metastatic disease
Exceptions:
- Patients with GIST who fail Gleevec are eligible
- Patients who have had adjuvant/neoadjuvant chemotherapy are also eligible
Known brain metastases
- Exception: Patients with treated brain metastatic disease with stable symptoms after treatment for >= 1 month
Contacts and Locations More Information
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00087074 History of Changes |
| Other Study ID Numbers: | NCI-2012-02809, MC027B, N01CM17104, CDR0000372912 |
| Study First Received: | July 8, 2004 |
| Last Updated: | January 15, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Sarcoma Gastrointestinal Stromal Tumors Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases 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 May 21, 2013