Combination Chemotherapy in Treating Patients With Metastatic Cancer of an Unknown Site of Origin

September 19, 2013 updated by: The Christie NHS Foundation Trust

An Open Label Prospective Randomised Study Comparing The Use Of Vincristine, Adriamycin And Cyclophosphamide (VAC) Versus Epirubicin, Cisplatin And Continuous 5-Flourouracil (ECF) In Patients With Unknown Primary Carcinoma (UPC)

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is more effective for metastatic cancer of an unknown site of origin.

PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have metastatic cancer of an unknown site of origin.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Compare the efficacy of the regimens, in terms of tumor response, progression-free survival, and overall survival of vincristine, doxorubicin, and cyclophosphamide vs epirubicin, cisplatin, and fluorouracil in patients with metastatic carcinoma of unknown primary. II. Compare the toxicity of these regimens in these patients. III. Compare quality of life and symptom control in patients treated with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to presence of liver metastases (yes vs no) and type of tumor (adenocarcinoma vs non-adenocarcinoma). Patients are randomized to one of two treatment arms. Arm I: Patients receive vincristine IV, doxorubicin IV, and cyclophosphamide IV on day 1. Arm II: Patients receive epirubicin IV and cisplatin IV over 4 hours on day 1 and fluorouracil IV continuously on days 1-21. Treatment in both arms repeats every 3 weeks for 3-6 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, at the end of courses 2, 4, and 6, and 1 month after completion of therapy. Patients are followed at 1 month and then until death.

PROJECTED ACCRUAL: A total of 398 patients (199 per treatment arm) will be accrued for this study.

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • Manchester, England, United Kingdom, M20 4BX
        • Christie Hospital N.H.S. Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS: Histologically confirmed metastatic carcinoma of unknown primary Adenocarcinoma or non-adenocarcinoma No axillary lymph node metastases as sole site of disease in female patients No peritoneal carcinomatosis as sole site of disease in female patients No squamous cell carcinoma in cervical lymph nodes as sole site of disease in male or female patients No neuroendocrine tumors No elevated alpha-fetoprotein, beta-HCG, or PSA

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: More than 3 months Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin less than 1.8 mg/dL Renal: Creatinine less than 1.5 times upper limit of normal (ULN) Urea less than 1.5 times ULN Glomerular filtration rate at least 60 mL/min Cardiovascular: LVEF at least 50% by echocardiogram or MUGA scan No uncontrolled angina pectoris No heart failure No clinically significant uncontrolled cardiac arrhythmias No abnormal EKG Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 1 year after study No other prior malignancy except adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix No medical or psychiatric condition that would preclude study No other serious uncontrolled medical condition

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for carcinoma of unknown primary Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy allowed except to sole site of measurable or evaluable disease Concurrent palliative radiotherapy allowed except to sole site of measurable or evaluable disease Surgery: Not specified Other: No other concurrent experimental drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Christie NHS Foundation Trust

Investigators

  • Study Chair: Juan W. Valle, MD, The Christie NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 1998

Study Registration Dates

First Submitted

August 10, 2001

First Submitted That Met QC Criteria

February 26, 2004

First Posted (Estimate)

February 27, 2004

Study Record Updates

Last Update Posted (Estimate)

September 20, 2013

Last Update Submitted That Met QC Criteria

September 19, 2013

Last Verified

February 1, 2002

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000068792
  • CHNT-VAC-VS-ECF
  • EU-20041

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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