Gemcitabine Hydrochloride in Treating Patients With Pancreatic Cancer That Has Been Removed by Surgery
This study is currently recruiting participants.
Verified August 2011 by National Cancer Institute (NCI)
Sponsor:
Federation Francophone de Cancerologie Digestive
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01416662
First received: August 12, 2011
Last updated: NA
Last verified: August 2011
History: No changes posted
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Pancreatic Cancer |
Drug: gemcitabine hydrochloride Genetic: mutation analysis Genetic: polymorphism analysis Other: laboratory biomarker analysis Other: pharmacogenomic studies Other: pharmacological study Procedure: adjuvant therapy |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Pharmacogenetics of Gemcitabine: Study of the Impact of Genetic Polymorphism of Cytidine Deaminase (CDA) on Toxicity in Resected Pancreatic Adenocarcinomas |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Ability of cytidine deaminase (CDA) to predict the occurrence of early (during the first 2 courses) severe hematological toxicity (grade 3 or 4), induced by gemcitabine hydrochloride [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Ability of CDA to predict the occurrence of severe non-hematological toxicity (grade 3 or 4), early (during the first 2 courses), and during the following courses, induced by gemcitabine hydrochloride [ Designated as safety issue: Yes ]
- Ability of CDA to predict the occurrence of severe hematological toxicity (grade 3 or 4) during all courses, induced by gemcitabine hydrochloride [ Designated as safety issue: Yes ]
- Impact of CDA status on gemcitabine hydrochloride pharmacokinetics and the ratio of gemcitabine hydrochloride/dFdU metabolization [ Designated as safety issue: No ]
- Genotype to phenotype study of the CDA gene [ Designated as safety issue: No ]
- New mutations on the CDA gene [ Designated as safety issue: No ]
| Estimated Enrollment: | 120 |
| Study Start Date: | June 2011 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
- To determine the ability of cytidine deaminase (CDA) to predict the occurrence of early (during the first 2 courses) severe hematological toxicity (grade 3 or 4), induced by gemcitabine hydrochloride in patients with resected pancreatic adenocarcinoma.
Secondary
- To determine the ability of CDA to predict the occurrence of severe non-hematological toxicity (grade 3 or 4), early (during the first 2 courses), and during the following courses, induced by gemcitabine hydrochloride.
- To determine the ability of CDA to predict the occurrence of severe hematological toxicity (grade 3 or 4) during all courses, induced by gemcitabine hydrochloride.
- To determine the impact of CDA status on gemcitabine hydrochloride pharmacokinetics and the ratio of gemcitabine hydrochloride/dFdU metabolization.
- To study genotype to phenotype of the CDA gene.
- To identify new mutations on the CDA gene.
- To evaluate the relationship between CDA status and global survival. (Exploratory)
OUTLINE: This is a multicenter study.
Within 8 weeks of resection, patients receive adjuvant gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
Blood samples are collected periodically for pharmacogenetic and biomarker studies. Some patients may undergo blood sample collection for pharmacokinetic studies.
After completion of study, patients are followed up periodically.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01416662
Locations
| France | |
| CHU de la Timone | Recruiting |
| Marseille, France, 13385 | |
| Contact: Contact Person 33-4-9138-6023 laetitia.dahan@mail.ap-hm.fr | |
Sponsors and Collaborators
Federation Francophone de Cancerologie Digestive
Investigators
| Principal Investigator: | Laetitia Dahan, MD | CHU de la Timone |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT01416662 History of Changes |
| Other Study ID Numbers: | CDR0000703689, FFCD-1004, EU-21118, EUDRACT-2010-022987-11 |
| Study First Received: | August 12, 2011 |
| Last Updated: | August 12, 2011 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
adenocarcinoma of the pancreas stage IA pancreatic cancer stage IB pancreatic cancer stage IIA pancreatic cancer |
Additional relevant MeSH terms:
|
Adenocarcinoma Pancreatic Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Digestive System Neoplasms Neoplasms by Site Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Gemcitabine |
Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents |
ClinicalTrials.gov processed this record on May 23, 2013