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UNKNOWNPHASE3

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

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)

NCT00022178•The Christie NHS Foundation Trust

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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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion 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

Locations (1)

Christie Hospital N.H.S. Trust

Manchester, England, United Kingdom

Key Dates

Start Date

December 1, 1998

Last Updated

September 20, 2013

Conditions

Carcinoma of Unknown Primary

Interventions

cisplatin

DRUG

cyclophosphamide

DRUG

doxorubicin hydrochloride

DRUG

epirubicin hydrochloride

DRUG

fluorouracil

DRUG

vincristine sulfate

DRUG

Intensity Modulated Proton or X-Ray Therapy After Surgery for Treatment of Head and Neck Cancer, the HEADLIGHT Study

NCT05075980

Head and Neck CarcinomaHead and Neck Carcinoma of Unknown Primary+10 more

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RECRUITINGPHASE2

Lovastatin and Pembrolizumab for the Treatment of Patients With Recurrent or Metastatic Head and Neck Cancer, LAPP Trial

NCT06636734

Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Human Papillomavirus-Related Neck Squamous Cell Carcinoma of Unknown Primary+20 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 20, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Intensity Modulated Proton or X-Ray Therapy After Surgery for Treatment of Head and Neck Cancer, the HEADLIGHT Study

Lovastatin and Pembrolizumab for the Treatment of Patients With Recurrent or Metastatic Head and Neck Cancer, LAPP Trial

Combining Immunotherapy Salvage Surgery & IORT Tx Persistent/Recurrent Head & Neck Cancer

Blood Tests and Questionnaires in Studying Adherence to Preventative Swallowing Exercises in Participants With Metastatic Head and Neck Cancer

Pembrolizumab in Treating Patients With Rare Tumors That Cannot Be Removed by Surgery or Are Metastatic

Study of Mucosal Sparing Adjuvant Radiotherapy After Surgical Exploration in HPV+ Head and Neck Cancer of Unknown Primaries