Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00376688
Other study ID # NCI-2012-02703
Secondary ID NCI-2012-02703NC
Status Completed
Phase Phase 2
First received
Last updated
Start date July 11, 2006
Est. completion date December 16, 2019

Study information

Verified date January 2020
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase II trial studies how well temsirolimus works in treating patients with breast cancer that has spread to other places in the body. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.


Description:

PRIMARY OBJECTIVES:

I. To determine the overall activity (as defined by complete response [CR] + partial response [PR] + stable disease [SD] for >= 24 weeks) of a weekly 25 mg intravenous dose of temsirolimus in patients with locally advanced or metastatic breast cancer.

II. To compare the activity of temsirolimus in patients with locally advanced or metastatic breast cancer whose primary tumors have mutations in the PIK3CA or PTEN gene with those whose tumors do not have a mutation in the PIK3CA gene.

III. To examine correlations between antitumor activity of temsirolimus and alterations in expression of genes in the PI3K pathway in primary tumor biopsy specimens.

OUTLINE:

Patients receive temsirolimus intravenously (IV) over 30 minutes weekly. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.


Other known NCT identifiers
  • NCT00360542

Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date December 16, 2019
Est. primary completion date June 12, 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients must have histologically or cytologically confirmed metastatic or recurrent breast cancer not amenable to local therapy (surgery and radiation) (histologic/cytologic confirmation of recurrence preferred, but not required)

- Either the primary or metastatic tumor must be positive for estrogen receptor (>= 1% by immunohistochemical staining) and/or progesterone receptor (>= 1% by immunohistochemical staining) and/or human epidermal growth factor receptor (HER2neu) (3+ immunohistochemical staining or fluorescence in situ hybridization [FISH] positive)

- Patients must have measurable disease; measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan

- There are no limitations on the number of prior therapy regimens; however, patients who have had prior exposure to rapamycin or any other mechanistic target of rapamycin (mTOR) inhibitor are excluded from the trial

- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

- Absolute neutrophil count >= 1,500/uL

- Platelets >= 100,000/uL

- Total bilirubin =< institutional upper limit of normal

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 times institutional upper limit of normal

- Creatinine =< 2.0 x normal institutional upper limit of normal

- Cholesterol =< 350 mg/dL (fasting)

- Triglycerides =< 400 mg/dL (fasting)

- Albumin >= 3.3 mg/dL

- Women of child-bearing potential and men must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; women of child-bearing potential must have a negative pregnancy test prior to treatment on study; breastfeeding should be discontinued if the mother is treated with temsirolimus

- Ability to understand and the willingness to sign a written informed consent document

- Tissue for correlative studies must be available and the subject must agree to use of tissue for these studies

Exclusion Criteria:

- Patients must be off of hormonal agents used for the treatment of breast cancer for one week with the exception that premenopausal women who have been on a gonadotropin-releasing hormone (GnRH) agonist and subsequently progressed may, at the discretion of the treating physician, continue on the GnRH agonist

- Patients should have recovered from the adverse effects of prior chemotherapy; in general, this will mean that the patient would have been due or overdue for the next dose of the prior regimen: three weeks should have elapsed for a regimen administered once every three weeks, etc

- Radiotherapy should have been completed

- Three weeks should have elapsed since prior therapy with monoclonal antibodies

- Patients may not be receiving any other investigational agents or herbal preparations; patients may not be taking corticosteroids except in low doses as replacement for adrenal insufficiency or for short -term (less than 5 days) use for other reasons

- Patients with known brain metastases are not permitted on study unless the metastases have been controlled by prior surgery or radiotherapy, and the patient has been neurologically stable and off of steroids for at least 4 weeks

- Patients cannot be receiving enzyme-inducing antiepileptic drugs (enzyme-inducing antiepileptic drugs [EIAEDs]; e.g., phenytoin, carbamazepine, phenobarbital) nor any other CYP3A4 inducer such as rifampin or St. John's wort, as these may decrease temsirolimus levels; use of agents that potently inhibit CYP3A (and hence may raise temsirolimus levels), such as ketoconazole, is discouraged, but not specifically prohibited; CCI-779 can inhibit CYP2D6, and may decrease metabolism (and increase drug levels) of drugs that are substrates for CYP2D6, such as codeine; the appropriateness of use of such agents is left to physician discretion; if there is any doubt about eligibility based on concomitant medication, the study chair, Dr Fleming, should be contacted; all concomitant medications must be recorded

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled symptomatic cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

- Human immunodeficiency virus (HIV)-positive patients receiving combination anti-retroviral therapy are excluded from the study

- Patients with known hypersensitivity reactions to macrolide antibiotics (such as erythromycin, clarithromycin, and azithromycin) are not eligible for this trial

Study Design


Intervention

Other:
Laboratory Biomarker Analysis
Correlative studies
Drug:
Temsirolimus
Given IV

Locations

Country Name City State
United States University of Chicago Comprehensive Cancer Center Chicago Illinois
United States Washington University School of Medicine Saint Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical Benefit Rate (Complete Response, Partial Response, or Stable Disease) Response evaluation criteria in solid tumors (RECIST) criteria version 1.0 was used for response evaluation. Clinical benefit rate is defined as the proportion of subjects experiencing a complete response (CR), partial response (PR), or stable disease (SD) for at least 24 weeks.
Evaluation of target lesions: Complete Response (CR)-- Disappearance of all target lesions; Partial Response (PR)-- At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Stable Disease (SD)-- Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started;
Evaluation of non-target lesions: Complete Response (CR)-- Disappearance of all non-target lesions and normalization of tumor marker level; Incomplete Response/ Stable Disease (SD)-- Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits
Up to 24 months
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04052555 - Testing the Addition of an Anti-cancer Drug, Berzosertib, to the Usual Treatment (Radiation Therapy) for Chemotherapy-Resistant Triple-Negative and Estrogen and/or Progesterone Receptor Positive, HER2 Negative Breast Cancer Phase 1
Recruiting NCT04521764 - A Vaccine (MV-s-NAP) for the Treatment of Patients With Invasive Metastatic Breast Cancer Phase 1
Completed NCT00100750 - Tipifarnib and Gemcitabine Hydrochloride in Treating Women With Metastatic Breast Cancer Phase 1/Phase 2
Suspended NCT03737695 - Clinical Information and Biospecimen Collection From Patients With Recurrent or Stage IV Breast Cancer
Active, not recruiting NCT02595905 - Cisplatin With or Without Veliparib in Treating Patients With Recurrent or Metastatic Triple-Negative and/or BRCA Mutation-Associated Breast Cancer With or Without Brain Metastases Phase 2
Terminated NCT02149173 - F-18 FES PET/CT in Measuring Hormone Expression in Patients With Primary, Recurrent, or Metastatic Breast Cancer Undergoing Endocrine-Targeted Therapy N/A
Completed NCT00390455 - Fulvestrant With or Without Lapatinib in Treating Postmenopausal Women With Stage III or Stage IV Breast Cancer That is Hormone Receptor-Positive Phase 3
Recruiting NCT03213041 - Pembrolizumab and Carboplatin in Treating Patients With Circulating Tumor Cells Positive Metastatic Breast Cancer Phase 2
Not yet recruiting NCT04529044 - 177Lu-DOTATATE for the Treatment of Stage IV or Recurrent Breast Cancer Phase 2
Completed NCT00699491 - Cixutumumab and Temsirolimus in Treating Patients With Locally Recurrent or Metastatic Breast Cancer Phase 1/Phase 2
Completed NCT03364348 - 4-1BB Agonist Monoclonal Antibody PF-05082566 With Trastuzumab Emtansine or Trastuzumab in Treating Patients With Advanced HER2-Positive Breast Cancer Phase 1
Terminated NCT01149356 - RO4929097 And Exemestane in Treating Pre- and Postmenopausal Patients With Advanced or Metastatic Breast Cancer Phase 1
Completed NCT01964924 - Trametinib and Akt Inhibitor GSK2141795 in Treating Patients With Metastatic Triple-Negative Breast Cancer Phase 2
Completed NCT00785291 - Paclitaxel, Nab-paclitaxel, or Ixabepilone With or Without Bevacizumab in Treating Patients With Stage IIIC or Stage IV Breast Cancer Phase 3
Terminated NCT02370264 - Questionnaires in Identifying Upper Extremity Function and Quality of Life After Treatment in Patients With Breast Cancer N/A
Terminated NCT01071564 - RO4929097 and Vismodegib in Treating Patients With Breast Cancer That is Metastatic or Cannot Be Removed By Surgery Phase 1
Terminated NCT00998738 - Calcium and Magnesium in Preventing Peripheral Neuropathy Caused by Ixabepilone in Patients With Breast Cancer Phase 3
Active, not recruiting NCT00520975 - First-Line Chemotherapy and Trastuzumab With or Without Bevacizumab in Treating Patients With Metastatic Breast Cancer That Overexpresses HER-2/NEU Phase 3
Completed NCT01251874 - Veliparib and Carboplatin in Treating Patients With HER2-Negative Metastatic Breast Cancer Phase 1
Active, not recruiting NCT03281902 - Genetic Analysis in Blood and Tumor Samples From Patients With Advanced or Metastatic Estrogen Receptor Positive and HER2 Negative Breast Cancer Receiving Palbociclib and Endocrine Therapy