NCT01416662

Brief Summary

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment. PURPOSE: This clinical trial is studying gemcitabine hydrochloride in treating patients with pancreatic cancer that has been removed by surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P75+ for phase_2 pancreatic-cancer

Timeline
Completed

Started Jun 2011

Typical duration for phase_2 pancreatic-cancer

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

Study Start

First participant enrolled

June 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 15, 2011

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

May 30, 2016

Status Verified

May 1, 2016

Enrollment Period

3.6 years

First QC Date

August 12, 2011

Last Update Submit

May 27, 2016

Conditions

Pancreatic Cancer

Keywords

adenocarcinoma of the pancreasstage IA pancreatic cancerstage IB pancreatic cancerstage IIA pancreatic cancer

Outcome Measures

Primary Outcomes (1)

  • capability of CDA to predict the occurrence of early severe hematological toxicity upon gemcitabine

    2 months

Secondary Outcomes (1)

  • Overall Survival

    2 years

Study Arms (1)

gemcitabine

OTHER

gemcitabine

Drug: gemcitabine hydrochloride

Interventions

gemcitabine hydrochlorideDRUG
gemcitabine

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the pancreas * No metastatic or locally advanced (nonresectable) disease * Must have undergone curative surgical resection * Must have macroscopically complete (R0 or R1) surgical outcome * Adjuvant treatment with gemcitabine hydrochloride (for 6 months) is necessary, and able to start treatment within 8 weeks of surgical resection * No ampullomas or endocrine carcinomas PATIENT CHARACTERISTICS: * WHO performance status 0-2 * Neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Alkaline phosphatases ≤ 5 times upper limit of normal * Total bilirubin ≤ 50 µmol/L * Creatinine clearance ≥ 60 mL/min * Not pregnant or nursing * Able to start adjuvant chemotherapy within 8 weeks of surgery * No evolving infectious syndrome (fever \> 38°C or abscess) * No contraindication for gemcitabine hydrochloride * No prior malignant tumor except for cutaneous basocellular carcinoma or in situ cervical epithelioma (prior history of malignant tumor diagnosed and treated more than 10 years ago allowed, except for breast cancer and melanoma) PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No chemotherapy or radiotherapy within the past 10 years * No prior ablation surgery leaving macroscopic tumor residues (R2)

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

Sponsors & Collaborators

Study Sites (1)

CHU de la Timone

Marseille, 13385, France

Location

Related Publications (1)

  • Serdjebi C, Gagniere J, Desrame J, Fein F, Guimbaud R, Francois E, Andre T, Seitz JF, Monterymard C, Arsene D, Volet J, Abakar-Mahamat A, Lecomte T, Guerin-Meyer V, Legoux JL, Deplanque G, Guillet P, Ciccolini J, Lepage C, Dahan L. FFCD-1004 Clinical Trial: Impact of Cytidine Deaminase Activity on Clinical Outcome in Gemcitabine-Monotherapy Treated Patients. PLoS One. 2015 Aug 26;10(8):e0135907. doi: 10.1371/journal.pone.0135907. eCollection 2015.

    PMID: 26308942RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Laetitia Dahan, MD

    CHU de la Timone

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2011

First Posted

August 15, 2011

Study Start

June 1, 2011

Primary Completion

January 1, 2015

Study Completion

September 1, 2015

Last Updated

May 30, 2016

Record last verified: 2016-05

Locations

FR(1)