NCT00072436

Brief Summary

This phase I trial is studying the side effects and best dose of gemcitabine hydrochloride and alvocidib in treating patients with solid tumors. Drugs used in chemotherapy, such as gemcitabine hydrochloride and alvocidib, use different ways to stop tumor cells from dividing so they stop growing or die. Combining 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
58

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 6, 2003

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Last Updated

July 2, 2013

Status Verified

July 1, 2013

Enrollment Period

5.5 years

First QC Date

November 4, 2003

Last Update Submit

July 1, 2013

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (2)

  • Dose-limiting toxicity (DLT) graded by National Cancer Institute (NCI) Common Toxicity Criteria

    28 days

  • Maximum tolerated dose, defined as one dose level below the dose that induces DLT in more than 1/6 patients

    28 days

Study Arms (1)

Treatment

EXPERIMENTAL

Some patients receive an initial dose of alvocidib IV over 1-7 hours on day 1 (course 0). Beginning 1 week later and for all subsequent courses, all patients receive gemcitabine hydrochloride IV over 60-150 minutes on days 1 and 15 and alvocidib IV over 1-7 hours on days 2 and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of gemcitabine hydrochloride and 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. Once the MTD is determined, up to 10 additional patients receive treatment at that dose.

Drug: gemcitabine hydrochlorideDrug: alvocidibOther: pharmacological study

Interventions

gemcitabine hydrochlorideDRUG

Given IV

Also known as: dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar
Treatment
alvocidibDRUG

Given IV

Also known as: FLAVO, flavopiridol, HMR 1275, L-868275
Treatment
pharmacological studyOTHER

Correlative studies

Also known as: pharmacological studies
Treatment

Eligibility Criteria

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

You may qualify if:

  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active infection
  • No severe malnutrition
  • No more than 2 prior chemotherapy regimens:
  • Prior combined modality therapy (e.g., full-dose chemotherapy with radiosensitizing chemotherapy and radiotherapy) is considered 1 prior regimen if all therapy was delivered as part of 1 comprehensive treatment plan
  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • No other concurrent chemotherapy
  • At least 6 months since prior radiotherapy to the lung parenchyma or mediastinum and no evidence of radiation pneumonitis on chest CT scan
  • At least 4 weeks since other prior radiotherapy and recovered
  • No prior radiotherapy to more than 50% of marrow volume
  • No concurrent radiotherapy
  • Histologically confirmed solid tumor for which gemcitabine is a treatment option OR for which no efficacious therapy exists
  • Must meet criteria for 1 of the following:
  • Measurable disease:
  • +38 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

MeSH Terms

Interventions

Gemcitabinealvocidib

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Geoffrey Shapiro

    Dana-Farber Cancer Institute

    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

November 4, 2003

First Posted

November 6, 2003

Study Start

September 1, 2003

Primary Completion

March 1, 2009

Last Updated

July 2, 2013

Record last verified: 2013-07

Locations

US(3)