NCT00004144

Brief Summary

RATIONALE: 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. PURPOSE: Phase I trial to study the effectiveness of bryostatin 1 plus gemcitabine in treating patients who have advanced cancer that has not responded to previous treatment.

Trial Health

87
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

Timeline
Completed

Started May 2000

Longer than 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 1999

Completed
5 months until next milestone

Study Start

First participant enrolled

May 1, 2000

Completed
2.7 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

April 24, 2014

Status Verified

April 1, 2014

Enrollment Period

6.6 years

First QC Date

December 10, 1999

Last Update Submit

April 22, 2014

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Study Arms (1)

bryostatin 1 & gemcitabine hydrochloride

EXPERIMENTAL
Drug: bryostatin 1Drug: gemcitabine hydrochloride

Interventions

bryostatin 1DRUG
bryostatin 1 & gemcitabine hydrochloride
gemcitabine hydrochlorideDRUG
bryostatin 1 & gemcitabine hydrochloride

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically proven advanced cancer (except hematological cancers) for which there is no standard therapy or have failed standard therapies * Measurable or evaluable disease * Clinically controlled brain metastases allowed PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * SWOG 0-2 Life expectancy: * At least 3 months Hematopoietic: * Hemoglobin at least 8.0 g/dL * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) (elevated bilirubin due to Gilbert's syndrome allowed if direct bilirubin normal) * AST less than 2.5 times ULN Renal: * Creatinine normal Cardiovascular: * No active cardiac disease Other: * Not pregnant or nursing * Fertile patients must use effective contraception * No concurrent bacterial infection requiring antibiotics * No serious concurrent medical condition PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent immunotherapy Chemotherapy: * At least 3 weeks since systemic cytotoxic chemotherapy (including gemcitabine) and recovered * No other concurrent chemotherapy Endocrine therapy: * Prior hormonal therapy allowed * No concurrent hormonal therapy (excluding contraceptives, appetite stimulants, or replacement steroids) Radiotherapy: * At least 3 weeks since radiotherapy to large areas of active bone marrow and recovered * No concurrent radiotherapy Surgery: * Recovered from prior major surgery Other: * No concurrent antiviral nucleosides * At least 1 month since prior investigational agents * No other concurrent experimental medications

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

Sponsors & Collaborators

Study Sites (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Related Publications (1)

  • El-Rayes BF, Gadgeel S, Shields AF, Manza S, Lorusso P, Philip PA. Phase I study of bryostatin 1 and gemcitabine. Clin Cancer Res. 2006 Dec 1;12(23):7059-62. doi: 10.1158/1078-0432.CCR-06-1419.

    PMID: 17145828RESULT

MeSH Terms

Interventions

bryostatin 1Gemcitabine

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Philip A. Philip, MD, PhD, FRCP

    Barbara Ann Karmanos Cancer Institute

    STUDY CHAIR

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

December 10, 1999

First Posted

January 27, 2003

Study Start

May 1, 2000

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

April 24, 2014

Record last verified: 2014-04

Locations

US(1)