NCT00098579

Brief 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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 8, 2004

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Last Updated

March 19, 2013

Status Verified

March 1, 2013

Enrollment Period

6.8 years

First QC Date

December 7, 2004

Last Update Submit

March 18, 2013

Conditions

Gastrointestinal Stromal TumorRecurrent Adult Soft Tissue SarcomaStage IV Adult Soft Tissue Sarcoma

Outcome Measures

Primary Outcomes (1)

  • MTD of alvocidib when given every three weeks in conjunction with doxorubicin hydrochloride

    Defined as the dose level immediately preceding the dose where 2 or more patients experienced DLT.

    Course 1

Secondary Outcomes (3)

  • Dose limiting toxicity

    Weekly during course 1 at initiation of each course thereafter

  • Clinical pharmacokinetics of the regimen

    Week 1

  • Therapeutic activity of alvocidib in combination with doxorubicin hydrochloride in patients with advanced solid tumors

    Every 2 courses for the first 6 courses and every 3 courses thereafter

Study Arms (1)

Treatment (chemotherapy)

EXPERIMENTAL

Patients receive doxorubicin hydrochloride IV over 5-10 minutes and alvocidib IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients reaching a cumulative doxorubicin dose of 600 mg/m\^2 or experiencing cardiotoxicity may receive alvocidib alone at the discretion of the investigator. Cohorts of 3-6 patients receive escalating doses of alvocidib until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Ten additional patients receive treatment at the MTD. Patients are followed every 3 months for 1 year.

Drug: alvocidibDrug: doxorubicin hydrochloride

Interventions

alvocidibDRUG

Given IV

Also known as: FLAVO, flavopiridol, HMR 1275, L-868275
Treatment (chemotherapy)
doxorubicin hydrochlorideDRUG

Given IV

Also known as: ADM, ADR, Adria, Adriamycin PFS, Adriamycin RDF
Treatment (chemotherapy)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +32 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Gastrointestinal Stromal TumorsSarcoma

Interventions

alvocidibDoxorubicin

Condition Hierarchy (Ancestors)

Neoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

DaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydrates

Study Officials

  • David D'Adamo

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 7, 2004

First Posted

December 8, 2004

Study Start

October 1, 2004

Primary Completion

July 1, 2011

Last Updated

March 19, 2013

Record last verified: 2013-03

Locations

US(1)