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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)


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Carcinoma of Unknown Primary

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Trial Information

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)


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.

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Juan W. Valle, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Christie Hospital NHS Foundation Trust

Authority:

United States: Federal Government

Study ID:

CDR0000068792

NCT ID:

NCT00022178

Start Date:

December 1998

Completion Date:

Related Keywords:

  • Carcinoma of Unknown Primary
  • adenocarcinoma of unknown primary
  • squamous cell carcinoma of unknown primary
  • undifferentiated carcinoma of unknown primary
  • newly diagnosed carcinoma of unknown primary
  • Carcinoma
  • Neoplasms, Unknown Primary

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