NCT00007917

Brief Summary

Phase I trial to study the effectiveness of gemcitabine plus flavopiridol in treating patients who have advanced solid tumors. Drugs used in chemotherapy 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

87
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

Timeline
Completed

Started Jan 2001

Longer than P75 for phase_1

Geographic Reach
1 country

2 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

January 1, 2001

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2001

Completed
2.8 years until next milestone

First Posted

Study publicly available on registry

October 15, 2003

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

February 28, 2013

Status Verified

February 1, 2013

Enrollment Period

9.7 years

First QC Date

January 6, 2001

Last Update Submit

February 27, 2013

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Study Arms (1)

Arm I

EXPERIMENTAL

Patients receive gemcitabine IV over 1-2.5 hours on days 1 and 8 and flavopiridol IV continuously over 24 hours on days 2 and 9. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of gemcitabine and flavopiridol until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Drug: alvocidibDrug: gemcitabine hydrochloride

Interventions

alvocidibDRUG
Arm I
gemcitabine hydrochlorideDRUG
Arm I

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically proven solid tumor for which gemcitabine is a treatment option or for which no effective therapy exists * Previously untreated disease allowed * No large and potentially symptomatic pericardial effusion or undrained pleural effusion (with or without pleurodesis) * No CNS metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * At least 12 weeks Hematopoietic: * Absolute neutrophil count at least 2,000/mm3 * Platelet count at least 100,000/mm3 * No prior thrombotic events Hepatic: * Bilirubin no greater than 1.5 mg/dL * SGOT no greater than 2 times upper limit of normal Renal: * Creatinine no greater than 1.5 mg/dL Cardiovascular: * No clinically significant cardiac disease * No prior deep venous thrombus * No prior arterial vascular event * No prior myocardial infarction * No unstable angina * No prior transient ischemic attack or cerebrovascular accident * No cardiac arrhythmias that could be related to cardiac ischemia Pulmonary: * No clinically significant pulmonary disease * No history of pulmonary embolism Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No active infection * No severe malnutrition or intractable emesis * No chronic diarrheal disease within the past 6 months PRIOR CONCURRENT THERAPY: Chemotherapy: * No more than 1 prior chemotherapy regimen * At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * Prior gemcitabine or flavopiridol allowed * No other concurrent chemotherapy Radiotherapy: * At least 3 weeks since prior radiotherapy and recovered * No prior radiotherapy to more than 50% of bone marrow * No concurrent radiotherapy

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

Sponsors & Collaborators

Study Sites (2)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Interventions

alvocidibGemcitabine

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Geoffrey Shapiro, MD, PhD

    Dana-Farber Cancer Institute

    STUDY CHAIR

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

January 6, 2001

First Posted

October 15, 2003

Study Start

January 1, 2001

Primary Completion

September 1, 2010

Study Completion

October 1, 2010

Last Updated

February 28, 2013

Record last verified: 2013-02

Locations

US(2)