Docetaxel and Imatinib Mesylate in Treating Patients With Locally Advanced or Metastatic Breast Cancer

NCT00080665 | Completed Phase 1

• 4 other identifiers: J0214 CDR0000354504P30CA006973JHOC-J0214SKCCC-J0214
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy such as docetaxel work in different ways to stop tumor cells from dividing so they stop growing or die. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Giving docetaxel with imatinib mesylate may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of docetaxel when given together with imatinib mesylate in treating patients with locally advanced or metastatic breast cancer.

Conditions

Breast Cancer

Keywords

male breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; stage IV breast cancer; recurrent breast cancer

Outcome Measures

Primary Outcomes (1)

• 2.1.1 To determine the safety profile, maximum tolerated dose, and recommended dose for subsequent phase II studies of a combination regimen of daily STI571 with weekly docetaxel on days 1, 8, and 15 in a 28-day cycle.

  4 weeks

Study Arms (1)

Imatinib mesylate and docetaxel

EXPERIMENTAL

Imatinib mesylate (400-600 mg, oral, once daily) and docetaxel (15-30 mg/m2, IV, weekly on days 1, 8, and 15) each 28 day cycle

Drug: docetaxel; Drug: imatinib mesylate

Interventions

docetaxel DRUG

Docetaxel (15-30 mg/m2, IV, weekly on days 1, 8, and 15) each 28 day cycle

Also known as: Taxotere

Imatinib mesylate and docetaxel

imatinib mesylate DRUG

Imatinib mesylate (400-600 mg, oral, once daily) each 28 day cycle

Also known as: Gleevec, STI571

Imatinib mesylate and docetaxel

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the breast * Stage IIIB, IIIC, or IV disease * Measurable or evaluable disease * Stable brain metastases allowed provided prior surgery or radiotherapy was completed more than 90 days ago * No documented or suspected leptomeningeal disease * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 18 and over Sex * Male or female Menopausal status * Not specified Performance status * ECOG 0-1 Life expectancy * Not specified Hematopoietic * Granulocyte count ≥ 1,500/mm\^3 * Hemoglobin ≥ 8.0 g/dL * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin ≤ upper limit of normal (ULN) * Meets 1 of the following criteria for AST or ALT AND alkaline phosphatase: * AST or ALT ≤ ULN AND alkaline phosphatase ≤ 5 times ULN * AST or ALT ≤ 2.5 times ULN AND alkaline phosphatase ≤ ULN * AST or ALT ≤ 1.5 times ULN AND alkaline phosphatase ≤ 2.5 times ULN * No known acute or chronic liver disease (e.g., chronic active hepatitis or cirrhosis) Renal * Creatinine ≤ 1.5 mg/dL Cardiovascular * No New York Heart Association class III or IV heart disease * No congestive heart failure * No myocardial infarction within the past 6 months Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for at least 3 months after study participation * No other primary malignancy except those malignancies that are clinically insignificant AND do not require active intervention * No other concurrent severe and/or life-threatening medical disease * No significant history of noncompliance to medical regimens or inability to grant reliable informed consent PRIOR CONCURRENT THERAPY: Biologic therapy * At least 14 days since prior systemic trastuzumab (Herceptin®) * No concurrent trastuzumab * No concurrent biologic therapy for the primary malignancy Chemotherapy * Prior taxane therapy, including docetaxel, in the adjuvant or metastatic setting allowed * At least 21 days since prior systemic chemotherapy (14 days for weekly or oral chemotherapy and 42 days for nitrosoureas or mitomycin) * No other concurrent chemotherapy Endocrine therapy * At least 14 days since prior systemic hormonal therapy * No concurrent antiestrogen therapy * No concurrent routine systemic corticosteroid therapy except as premedication for chemotherapy * Concurrent megestrol allowed only as an appetite stimulant Radiotherapy * See Disease Characteristics * At least 14 days since prior radiotherapy * No prior radiotherapy to only site of measurable/evaluable disease unless there is new evidence of post-radiotherapy disease progression * No concurrent radiotherapy Surgery * See Disease Characteristics * More than 2 weeks since prior major surgery Other * Recovered from all prior therapy * At least 14 days since prior daily or weekly systemic investigational treatment * No concurrent warfarin for full anticoagulation * Concurrent low-dose warfarin (e.g., 1 mg/day) allowed for prophylaxis of central venous access * No concurrent treatment with any of the following: * Phenobarbital * Phenytoin * Carbamazepine * Barbiturates * Rifampin * Hypericum perforatum (St. John's wort) * No other concurrent therapies for the primary malignancy * No other concurrent investigational drugs or systemic therapy * No concurrent bisphosphonates unless started before study therapy * No concurrent grapefruit juice

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Related Publications (2)

• Connolly RM, Rudek MA, Garrett-Mayer E, Jeter SC, Donehower MG, Wright LA, Zhao M, Fetting JH, Emens LA, Stearns V, Davidson NE, Baker SD, Wolff AC. Docetaxel metabolism is not altered by imatinib: findings from an early phase study in metastatic breast cancer. Breast Cancer Res Treat. 2011 May;127(1):153-62. doi: 10.1007/s10549-011-1413-6. Epub 2011 Feb 25.

  PMID: 21350820 RESULT

• Fackler MJ, Lopez Bujanda Z, Umbricht C, Teo WW, Cho S, Zhang Z, Visvanathan K, Jeter S, Argani P, Wang C, Lyman JP, de Brot M, Ingle JN, Boughey J, McGuire K, King TA, Carey LA, Cope L, Wolff AC, Sukumar S. Novel methylated biomarkers and a robust assay to detect circulating tumor DNA in metastatic breast cancer. Cancer Res. 2014 Apr 15;74(8):2160-70. doi: 10.1158/0008-5472.CAN-13-3392.

  PMID: 24737128 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Breast Neoplasms, Male

Interventions

Docetaxel; Imatinib Mesylate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Benzamides; Amides; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Antonio C. Wolff, MD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2004
• First Posted: April 8, 2004
• Study Start: December 1, 2003
• Primary Completion: January 1, 2007
• Study Completion: January 1, 2011
• Last Updated: April 24, 2018

Record last verified: 2018-04

Locations

US (1)