Tanespimycin in Treating Women With Refractory Locally Advanced or Metastatic Breast Cancer

NCT00096109 | Terminated Phase 2 Results

• 5 other identifiers: NCI-2012-03058C-2803U01CA062502U01CA062487CDR0000391198
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial is studying how well tanespimycin works in treating women with refractory locally advanced or metastatic breast cancer. Drugs used in chemotherapy, such as tanespimycin, work in different ways to stop tumor cells from dividing so they stop growing or die

Conditions

Recurrent Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer; Stage IV Breast Cancer

Outcome Measures

Primary Outcomes (3)

• Response Rate (Complete Response (CR) +Partial Response (PR)

  Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

  Up to 7 years

• Progression Free Survival (PFS)

  PFS is defined as either progression or death, whichever occurs first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

  Up to 7 years

• Her2/Neu Status

  Response rates will be estimated separately for her2/neu positive and her2/neu negative individuals along with 95% confidence intervals. PLEASE NOTE: IT WAS PROPOSED TO ANALYZE OUTCOME BY HER2 STATUS, NO DATA WAS COLLECTED OR EVALUATED.

  Baseline

Study Arms (1)

Treatment (tanespimycin)

EXPERIMENTAL

Patients receive tanespimycin IV over 1-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Drug: tanespimycin; Other: laboratory biomarker analysis

Interventions

tanespimycin DRUG

Given IV

Also known as: 17-AAG

Treatment (tanespimycin)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (tanespimycin)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary adenocarcinoma of the breast confirmed by histology or cytology
• Locally advanced or metastatic disease not amenable to surgery or radiation therapy with curative intent
• At least 1 measurable (target) lesion (i.e. any malignant tumor mass that can be accurately measured in at least 1 dimension of \>= 2 cm with conventional radiographic techniques or \>= 1 cm with magnetic resonance imaging \[MRI\] or spiral computerized tomography \[CT\] scans), not previously irradiated
• Progressive disease following hormonal therapy in appropriate patients (ER-positive and/or indolent disease)
• Progressive disease following treatment with both an anthracycline and a taxane (as adjuvant therapy or for metastatic disease) or contraindication to such treatment
• All previous cytotoxic chemotherapy must have been discontinued at least 4 weeks before study entry and all acute toxicity of prior therapy (excluding alopecia and neurotoxicity) must be resolved to NCI CTC (Version 3.0) grade =\< 1; patients must have discontinued treatment with nitrosoureas or mitomycin C at least 6 weeks prior to study entry
• All previous hormonal therapy must have been discontinued for at least 2 weeks before study entry
• Life expectancy of \>= 3 months
• ECOG performance status (PS) of 0-2
• Absolute neutrophil count (ANC) \>= 1500/mm\^3
• Platelets \>= 100,000/mm\^3
• Hemoglobin \>= 9.0 g/dL
• Creatinine (Cr) =\< upper limit of normal (ULN) or Cr Clearance \> 60 mL/min/m\^2
• Total bilirubin =\< 1.5X ULN
• Alanine aminotransferase (ALT) =\< 1.5X ULN or =\< 3X ULN with liver metastases

You may not qualify if:

• Current treatment with any other anti-neoplastic agent, including trastuzumab; patients may continue to receive zoledronic acid for bone metastases or hypercalcemia
• Radiation therapy within 2 weeks of enrollment or surgery within 4 weeks
• Known brain or leptomeningeal metastatic disease requiring active therapy; (Patients with asymptomatic previously treated metastases to these areas are eligible)
• Any of the following conditions within 6 months of enrollment: myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, coronary/peripheral artery bypass grafting; patients who have experienced a pulmonary embolus, deep venous thrombosis or other clinically significant thromboembolic event within 6 months of enrollment are eligible if they are clinically stable on anticoagulation therapy
• Current active infection, including known human immunodeficiency virus (HIV) positivity; for HIV patients on highly active antiretroviral therapy (HAART), the pharmacokinetics of the investigation agent may be seriously affected; when appropriate, 17-AAG will be studied in patients with HIV on HAART
• Serious allergy to eggs (i.e. hypotension, dyspnea, anaphylaxis, edema)
• Treatment with any agents that interact with cytochrome P450 3A should be avoided and used with caution, if necessary; when possible, patients should be switched to alternative medications; patients requiring anticoagulation should not be treated with Coumadin and should be switched to a low molecular weight heparin injection; patients receiving treatment with a low molecular weight heparin will require episodic monitoring with the anti-factor Xa heparin assay
• Previous (within 5 years of enrollment) or current malignancies at other sites, except adequately treated basal cell or squamous cell skin cancers and carcinoma in situ of the cervix
• Other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for study entry
• The use of concomitant medications that prolong or may prolong QTc are excluded
• Patients who have significant cardiac disease including heart failure that meets New York Heart Association (NYHA) class III and IV definitions, history of myocardial infarction within one year of study entry, uncontrolled dysrhythmias, or poorly controlled angina are excluded
• Patients who have a history of serious ventricular arrhythmia (VT or VF, \>= 3 beats in a row), QTc \>= 450 msec for men and 470 msec for women, or LVEF =\< 40% by MUGA are excluded
• Patients with a prior history of cardiac or pulmonary toxicity after receiving anthracyclines such as doxorubicin, daunorubicin, mitoxantrone, bleomycin or BCNU
• Patients with greater or equal to grade 2 pulmonary or cardiac symptoms prior to study entry
• Patients with a history of prior radiation that potentially included the heart in the field (e.g., mantle)

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

tanespimycin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

Because of the frequency of toxicities experienced by the pts \& lack of response, study closed to accrual before all 17 planned pts were enrolled. It was proposed to analyze outcome by HER2 status,but no HER2 data was collected.

Results Point of Contact

• Title: Elaina Gartner, M.D.
• Organization: Barbara Ann Karmanos Cancer Institute

egartner@seagen.com

(425) 527-4398

Study Officials

• Elaina Gartner

  Wayne State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2004
• First Posted: November 9, 2004
• Study Start: September 1, 2005
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: January 16, 2017
• Results First Posted: January 16, 2017

Record last verified: 2016-11

Locations

US (1)