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

Primary Purpose

Carcinoma of Unknown Primary

Status
Unknown status
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
cisplatin
cyclophosphamide
doxorubicin hydrochloride
epirubicin hydrochloride
fluorouracil
vincristine sulfate
Sponsored by
The Christie NHS Foundation Trust
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma of Unknown Primary focused on measuring adenocarcinoma of unknown primary, squamous cell carcinoma of unknown primary, undifferentiated carcinoma of unknown primary, newly diagnosed carcinoma of unknown primary

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Christie Hospital N.H.S. Trust

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 10, 2001
Last Updated
September 19, 2013
Sponsor
The Christie NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT00022178
Brief Title
Combination Chemotherapy in Treating Patients With Metastatic Cancer of an Unknown Site of Origin
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2002
Overall Recruitment Status
Unknown status
Study Start Date
December 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
The Christie NHS Foundation Trust

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma of Unknown Primary
Keywords
adenocarcinoma of unknown primary, squamous cell carcinoma of unknown primary, undifferentiated carcinoma of unknown primary, newly diagnosed carcinoma of unknown primary

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
epirubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Type
Drug
Intervention Name(s)
vincristine sulfate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan W. Valle, MD
Organizational Affiliation
The Christie NHS Foundation Trust
Official's Role
Study Chair
Facility Information:
Facility Name
Christie Hospital N.H.S. Trust
City
Manchester
State/Province
England
ZIP/Postal Code
M20 4BX
Country
United Kingdom

12. IPD Sharing Statement

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

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