Doxorubicin Hydrochloride and Alvocidib in Treating Patients With Metastatic or Recurrent Sarcoma That Cannot Be Removed By Surgery

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This phase I trial is studying the side effects and best dose of alvocidib when given with doxorubicin hydrochloride in treating patients with metastatic or recurrent sarcoma that cannot be removed by surgery. Drugs used in chemotherapy, such as doxorubicin hydrochloride and alvocidib, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Alvocidib may also help doxorubicin hydrochloride work better by making tumor cells more sensitive to the drug. Giving more than one drug may kill more tumor cells

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Alvocidib; Doxorubicin; Liposomal doxorubicin

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed soft-tissue sarcoma*

• Unresectable disease

• Locally recurrent or metastatic disease

• Disease amenable to biopsy (patients treated at the maximum tolerated dose only)

• No known prior or concurrent brain metastases

• Performance status - Karnofsky 60-100%

• Performance status - ECOG 0-2

• Absolute neutrophil count ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

• Bilirubin ≤ 1.5 mg/dL

• AST and ALT ≤ 2.5 times upper limit of normal

• Creatinine ≤ 1.5 mg/dL

• Creatinine clearance ≥ 60 mL/min

• Ejection fraction ≥ 50% by MUGA or echocardiogram

• No uncontrolled hypertension

• No myocardial infarction

• No New York Heart Association class II-IV congestive heart failure

• No unstable angina

• No serious cardiac arrhythmia requiring medication

• No peripheral vascular disease ≥ grade 2 within the past year

• No other clinically significant cardiac disease

• No prior deep vein thrombosis

• No other prior vascular thrombus

• No prior pulmonary embolism

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No symptomatic peripheral neuropathy ≥ grade 2

• No other malignancy within the past 5 years except adequately treated basal cell skin cancer or carcinoma in situ of the cervix

• Carcinoma in situ not considered a second malignancy

• No history of allergic reaction attributed to compounds of similar chemical or biologic composition to study drugs

• No psychiatric illness or social situation that would preclude study compliance

• No ongoing or active infection

• No other uncontrolled illness

• See Chemotherapy

• At least 3 weeks since prior immunotherapy and recovered

• At least 3 weeks since prior chemotherapy (6 weeks for carmustine or mitomycin) and recovered

• No more than 2 prior cytotoxic chemotherapy regimens

• Peroxisome proliferator-activated receptor (PPAR)-gamma agonists, thalidomide, or targeted therapy (i.e., tyrosine kinase inhibitors including imatinib mesylate, sorafenib, or sunitinib malate) do not count as a prior chemotherapy regimen

• No prior anthracyclines

• At least 3 weeks since prior radiotherapy and recovered

• No prior extensive radiotherapy to bone marrow-producing sites (e.g., radiotherapy to both the pelvis and spine)

• At least a 1 week washout period since prior tyrosine kinase inhibitors or other targeted therapy

• Concurrent low-dose warfarin (1 mg per day) to prevent thrombus of a central line allowed

• No concurrent combination antiretroviral therapy for HIV-positive patients

• No other concurrent investigational agents

• No other concurrent anticancer therapy