Radiation Therapy, Cisplatin, Fluorouracil, and Cetuximab in Treating Patients With Locally Advanced Anal Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
UNICANCER
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00955240
First received: August 7, 2009
Last updated: July 8, 2011
Last verified: July 2011
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Purpose
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as 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. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving radiation therapy together with combination chemotherapy and cetuximab may kill more tumor cells.
PURPOSE: This phase II trial is studying giving radiation therapy together with cisplatin, fluorouracil, and cetuximab to see how well it works in treating patients with locally advanced anal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Anal Cancer |
Biological: cetuximab Drug: cisplatin Drug: fluorouracil Other: laboratory biomarker analysis Radiation: radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Primary Purpose: Treatment |
| Official Title: | Phase II Nonrandomized Multicenter Study of the Impact of Radiochemotherapy (65 Gy + Cisplatin + 5FU) Combined With Cetuximab in Patients Presenting With Locally Advanced Anal Cancer |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Objective response (complete and partial) according to RECIST criteria at 8 weeks after completion of study treatment [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Survival rate at 3 and 5 years [ Designated as safety issue: No ]
- Colostomy-free survival at 3 and 5 years [ Designated as safety issue: No ]
- Duration of objective response [ Designated as safety issue: No ]
| Estimated Enrollment: | 77 |
| Study Start Date: | March 2009 |
OBJECTIVES:
Primary
- Evaluate the objective response (complete and partial) 8 weeks after completion of study treatment comprising radiotherapy, chemotherapy (fluorouracil and cisplatin), and cetuximab followed by additional radiotherapy in patients with locally advanced anal cancer.
Secondary
- Evaluate colostomy-free survival.
- Evaluate the local control rate (objective response and stabilization) at 8 weeks.
- Evaluate relapse-free survival at 5 years.
- Evaluate the intermediate objective response at the end of week 5 of radiotherapy.
- Evaluate overall survival at 5 years.
- Evaluate the duration of response.
- Evaluate acute toxicities according to CTCAE v3.0.
- Evaluate late toxicities at 5 years according to CTCAE v3.0.
- Study the tumor markers associated with response (survival without relapse) and toxicity.
- Study the genotypes of Fc-receptor immunoglobulins (FCGR2A and FCGR3) and their association with skin toxicity, objective survival, and relapse-free survival.
OUTLINE: This is a multicenter study.
Patients receive cetuximab IV on days 0, 7, 14, 21, 28, and 35; fluorouracil IV on days 7-10 and 35-38; and cisplatin IV over 2 hours on days 7 and 35. Beginning on day 7, patients also undergo radiotherapy 5 days a week for 5 weeks (weeks 2-6). Two weeks after finishing this treatment, patients undergo additional radiotherapy* 5 days a week for 2 weeks (weeks 9 and 10).
NOTE: *Some patients may undergo brachytherapy.
Blood and tissue samples are collected for further analysis.
After completion of study treatment, patients are followed up for 4 years.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed anal cancer
- Squamous cell disease
- Locally advanced, non-metastatic disease
One of the following clinical TNM stages:
- T2, N0, M0 (largest diameter ≥ 3 cm)
- T3-T4, N0, M0
- Any T, N1-N3, M0
- No undifferentiated small cell carcinoma or adenocarcinoma
- Measurable disease according to RECIST criteria
- Undergone endorectal ultrasound or MRI to evaluate the primary tumor
- Undergone thoraco-abdomino-pelvic scan to evaluate tumor extension
- Disease suitable to receive radiotherapy and chemotherapy
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Leukocytes ≥ 4,000/mm^3
- ANC ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 10 g/dL
- Creatinine clearance > 60 mL/min
- ALT and AST ≤ 5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 2.5 times ULN
- Total bilirubin ≤ 1.5 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- No history of cancer within the past 8 years except for in situ cervical cancer or previously treated basal cell carcinoma of the skin
- No contraindications to any component of study therapy
- No serious uncontrolled illness
- No symptomatic grade 1 angina pectoris or angina pectoris ≥ grade 2
- No congestive heart failure
- No peripheral sensory neuropathy
- No uncontrolled diabetes
- No HIV positivity
- No geographical, social, or psychological situations that preclude medical follow up
- Affiliated with a social security system
- No patient deprived of liberty or under trusteeship
PRIOR CONCURRENT THERAPY:
- Patients with a diverting colostomy are eligible
- No prior excision of this tumor
- No prior chemotherapy or radiotherapy for the treatment of this cancer or any other history of radiotherapy or pelvic brachytherapy
- No concurrent coumarin anticoagulants, phenytoin, sorivudine or brivudine, antacids, or allopurinol
- Not registered in another clinical trial with an experimental drug
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00955240
Locations
| France | |
| Institut Bergonie | |
| Bordeaux, France, 33076 | |
| CHU Hopital A. Morvan | |
| Brest, France, 29609 | |
| Centre Regional Francois Baclesse | |
| Caen, France, 14076 | |
| Centre Hospitalier Departemental | |
| La Roche Sur Yon, France, F-85025 | |
| Centre Oscar Lambret | |
| Lille, France, 59020 | |
| Centre Hospital Regional Universitaire de Limoges | |
| Limoges, France, 87042 | |
| Centre Leon Berard | |
| Lyon, France, 69373 | |
| Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle | |
| Montpellier, France, 34298 | |
| Centre Regional Rene Gauducheau | |
| Nantes-Saint Herblain, France, 44805 | |
| Centre Antoine Lacassagne | |
| Nice, France, 06189 | |
| Institut Curie Hopital | |
| Paris, France, 75248 | |
| Hopital Tenon | |
| Paris, France, 75970 | |
| Hopital Saint-Louis | |
| Paris, France, 75475 | |
| Centre Hospitalier Lyon Sud | |
| Pierre Benite, France, 69495 | |
| Hopital Charles Nicolle | |
| Rouen, France, 76031 | |
| Centre Hospitalier Prive Saint-Gregoire | |
| Saint-Gregoire, France, 35768 | |
| Groupe Oncorad Garonne | |
| Toulouse, France, 31300 | |
| Clinique Du Parc | |
| Toulouse, France, 31078 | |
| Centre Alexis Vautrin | |
| Vandoeuvre-les-Nancy, France, 54511 | |
| Institut Gustave Roussy | |
| Villejuif, France, F-94805 | |
Sponsors and Collaborators
UNICANCER
Investigators
| Principal Investigator: | Eric Deutsch, MD | Institut Gustave Roussy |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00955240 History of Changes |
| Other Study ID Numbers: | CDR0000642638, FRE-FNCLCC-ACCORD-16-0708, EU-20941, EUDRACT-2007-0 07029-38 |
| Study First Received: | August 7, 2009 |
| Last Updated: | July 8, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage II anal cancer stage IIIA anal cancer stage IIIB anal cancer squamous cell carcinoma of the anus |
Additional relevant MeSH terms:
|
Anus Neoplasms Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Anus Diseases Rectal Diseases |
Cetuximab Cisplatin Fluorouracil Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on May 23, 2013