Docetaxel Plus Carboplatin in Treating Patients With Advanced Cancer of the Esophagus

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT00003864
First received: November 1, 1999
Last updated: August 22, 2013
Last verified: August 2013
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of docetaxel plus carboplatin in treating patients who have advanced cancer of the esophagus.


Condition Intervention Phase
Esophageal Cancer
Drug: carboplatin
Drug: docetaxel
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase II Trial of Docetaxel and Carboplatin in Patients With Advanced Squamous Carcinoma of the Esophagus

Resource links provided by NLM:


Further study details as provided by Eastern Cooperative Oncology Group:

Study Start Date: July 1999
Primary Completion Date: January 2004 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES: I. Evaluate the objective response rate in patients with advanced squamous cell carcinoma of the esophagus treated with carboplatin and docetaxel. II. Assess the toxicity of this regimen in these patients. III. Assess the time to progression and overall survival of this patient population.

OUTLINE: Patients receive docetaxel IV over 1 hour on day 1, followed by carboplatin IV over 15-30 minutes on day 1. Treatment is repeated every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until year 2, every 6 months during years 2-5, and then annually thereafter until death.

PROJECTED ACCRUAL: A total of 18-35 patients will be accrued for this study at a rate of 30 patients per year.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically confirmed metastatic or incurable, locally advanced squamous cell carcinoma of the esophagus Measurable disease outside of a previously radiated field required

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin normal SGOT no greater than 2 times upper limit of normal Renal: Creatinine normal Cardiovascular: No congestive heart failure or angina pectoris, even if medically controlled No prior myocardial infarction within the past year No clinically significant conduction system abnormalities, such as 2nd or 3rd degree heart block or bundle branch block Pulmonary: Not specified Other: Not pregnant or nursing Fertile patients must use effective contraception No active infections or medical illnesses that are uncontrolled No second malignancy other than previously treated nonmelanoma skin cancer or carcinoma in situ of the cervix or a prior malignancy from which patient has been disease free for past 3 years Caloric intake greater than 1500 calories/day Fluid intake greater than 1500 mL/day

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: Not specified

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003864

  Show 74 Study Locations
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Study Chair: Coenraad F. Slabber, MD Pretoria Academic Hospital
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00003864     History of Changes
Other Study ID Numbers: CDR0000067028, E-2298
Study First Received: November 1, 1999
Last Updated: August 22, 2013
Health Authority: United States: Federal Government

Keywords provided by Eastern Cooperative Oncology Group:
stage III esophageal cancer
stage IV esophageal cancer
squamous cell carcinoma of the esophagus

Additional relevant MeSH terms:
Esophageal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site
Carboplatin
Docetaxel
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 23, 2014