Radiation Therapy and Docetaxel With Either Fluorouracil or Cisplatin as First-Line Therapy in Treating Patients With Metastatic Pancreatic Cancer That Cannot Be Removed By Surgery

Sponsor
UNICANCER (Other)
Overall Status
Completed
CT.gov ID
NCT00112697
Collaborator
(none)
71
10
2
100.8
7.1
0.1

Study Details

Study Description

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel, fluorouracil, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with chemotherapy may kill more tumor cells. It is not yet known whether radiation therapy, docetaxel, and fluorouracil are more effective than radiation therapy, docetaxel, and cisplatin as first-line therapy in treating pancreatic cancer.

PURPOSE: This randomized phase II trial is studying radiation therapy, docetaxel, and fluorouracil to see how well they work as first-line therapy compared to radiation therapy, docetaxel, and cisplatin in treating patients with metastatic pancreatic cancer that cannot be removed by surgery.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

OBJECTIVES:

Primary

  • Compare the 6-month progression-free survival rate in patients with unresectable metastatic adenocarcinoma of the pancreas treated with radiotherapy and docetaxel in combination with either fluorouracil or cisplatin as first-line therapy.

Secondary

  • Compare the toxicity of these regimens in these patients.

  • Compare the objective response rate in patients treated with these regimens.

  • Compare overall survival of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo radiotherapy to the celiac area once daily 5 days a week for 6 weeks. Patients also receive docetaxel IV weekly and fluorouracil IV daily for 6 weeks.

  • Arm II: Patients undergo radiotherapy and receive docetaxel as in arm I. Patients also receive cisplatin IV weekly for 6 weeks.

In both arms, patients experiencing disease progression after completion of chemoradiotherapy may receive additional courses of chemotherapy.

PROJECTED ACCRUAL: A total of 80 patients (40 per treatment arm) will be accrued for this study within 3 years.

Study Design

Study Type:
Interventional
Actual Enrollment :
71 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Randomized Phase II Trial Evaluating [Radiotherapy-Docetaxel-5 Fluorouracil] Association Versus [Radiotherapy-Docetaxel-Cisplatin] Association in Non Resecables First Line of Chemotherapy in Metastatics Pancreas Cancers Patients
Actual Study Start Date :
Oct 6, 2003
Actual Primary Completion Date :
Aug 1, 2008
Actual Study Completion Date :
Mar 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm 1

Drug: docetaxel

Drug: fluorouracil

Radiation: radiation therapy

Experimental: Arm 2

Drug: cisplatin

Drug: docetaxel

Radiation: radiation therapy

Outcome Measures

Primary Outcome Measures

  1. Progression-free survival rate at 6 months []

Secondary Outcome Measures

  1. Toxicity []

  2. Objective response rate []

  3. Overall survival []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
DISEASE CHARACTERISTICS:
  • Histologically or cytologically confirmed adenocarcinoma of the pancreas

  • No other pancreatic tumor type, including either of the following:

  • Neuroendocrine tumor

  • Ampulla of Vater carcinoma

  • Metastatic disease

  • Measurable or evaluable disease

  • Unresectable disease, defined as either of the following:

  • Failed prior attempt of surgical resection by laparotomy

  • Surgical resection contraindicated by radiographic criteria (e.g., arterial vascular invasion)

  • No cerebral metastases

PATIENT CHARACTERISTICS:

Age

  • 18 to 75

Performance status

  • Karnofsky 70-100%

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3

  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Bilirubin < 1.5 times upper limit of normal

  • No hepatic disturbance

Renal

  • Creatinine < 120 mmol/L

Cardiovascular

  • No untreated cardiac or coronary insufficiency

  • No uncontrolled symptomatic arrhythmia

  • No uncontrolled angina

Pulmonary

  • No uncontrolled respiratory insufficiency

Other

  • Not pregnant or nursing

  • Fertile patients must use effective contraception

  • No other malignancy except basal cell skin cancer or carcinoma in situ of the cervix

  • No peripheral neuropathy ≥ grade 2

  • No ongoing active infection

  • No other serious uncontrolled medical disorder that would preclude study treatment

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy to the celiac or pancreatic area

Surgery

  • See Disease Characteristics

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre Paul Papin Angers France 49036
2 Centre Oscar Lambret Lille France 59020
3 Polyclinique des Quatre Pavillons Lormont France 33310
4 Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes Marseille France 13273
5 Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle Montpellier France 34298
6 Centre Regional Rene Gauducheau Nantes-Saint Herblain France 44805
7 Centre Hospitalier Lyon Sud Pierre Benite France 69495
8 Centre Rene Huguenin Saint Cloud France 92210
9 Centre Alexis Vautrin Vandoeuvre-les-Nancy France 54511
10 Institut Gustave Roussy Villejuif France F-94805

Sponsors and Collaborators

  • UNICANCER

Investigators

  • Study Chair: Michel Ducreux, MD, PhD, Gustave Roussy, Cancer Campus, Grand Paris

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
UNICANCER
ClinicalTrials.gov Identifier:
NCT00112697
Other Study ID Numbers:
  • CDR0000430095
  • FRE-FNCLCC-ACCORD-09/0201
  • EU-20511
First Posted:
Jun 3, 2005
Last Update Posted:
Feb 17, 2021
Last Verified:
Feb 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by UNICANCER
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 17, 2021