Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Alternate Title

Combination Chemotherapy in Treating Patients With Cancer of Unknown Primary Origin

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over Other SA-JHB-CUP-1 NCI-F95-0033

Objectives

I.  Evaluate the response rate, duration of response, and survival following 
FLP (fluorouracil/l-leucovorin/cisplatin) in patients with measurable or 
evaluable carcinoma of unknown primary origin previously untreated with 
chemotherapy.

II.  Evaluate the toxicity of this regimen in these patients.

III.  Formulate prognostic variables that would identify favorable and 
unfavorable characteristics for treatment response (e.g., LDH, ECOG 
performance status, and number of metastatic sites).

Entry Criteria

Disease Characteristics:

Histologically documented carcinoma of unknown primary origin or
undifferentiated tumor
  Primary site unknown after the following:
     History and physical exam
     Appropriate diagnostic radiology
     Lab tests
     Pathology evaluation
     Abdominal CT with contrast (if clinically indicated)
     Upper GI (if clinically indicated)

No men with midline poorly differentiated carcinoma with or without elevated
AFP or beta-HCG
  Etoposide/cisplatin recommended for these patients

No CNS metastases

Disease measurable or evaluable
  No prior irradiation of indicator lesion

Prior/Concurrent Therapy:

Biologic therapy:
  No prior biologic therapy

Chemotherapy:
  No prior cytotoxic chemotherapy 

Endocrine therapy:
  Prior endocrine therapy allowed

Radiotherapy:
  At least 2 weeks since radiotherapy

Surgery:
  At least 3 weeks since any major surgery

Patient Characteristics:

Age:
  18 and over

Performance status:
  ECOG 0-2

Life expectancy:
  Greater than 12 weeks

Hematopoietic:
  WBC at least 4,000
  Platelets greater than 100,000

Hepatic:
  Bilirubin no greater than 2 x ULN
  SGOT and SGPT no greater than 2 x ULN

Renal:
  Creatinine no greater than 1.5 x ULN

Cardiovascular:
  No uncontrolled CHF
  No unstable angina
  No unstable arrhythmia
  No MI within 6 months

Other:
  No recent thromboembolism or requirement for anticoagulants
  No active infection
  No daily emesis or inability to tolerate solid foods
  No diarrhea
  No active pelvic inflammatory disease
  No active inflammatory bowel disease
  No seizures
  No major organ allograft
  No personal or family history of malignant hyperthermia
  No rheumatoid arthritis or other systemic connective tissue disorder
  No other chronic inflammatory disease
  No second malignancy within 2 years except:
     Nonmelanomatous skin cancer
     In situ cervical cancer
  No pregnant or nursing women
  Effective contraception required of fertile women

Expected Enrollment

30 evaluable patients will be studied over 24 months; if none of the first 14 
patients responds, the study will close.

Outline

The following acronyms are used:
  CDDP  Cisplatin, NSC-119875
  FLP   5-FU/L-CF/CDDP
  5-FU  Fluorouracil, NSC-19893
  L-CF  L-Leucovorin

2-Drug Combination Chemotherapy with Drug Modulation.  FLP.

Trial Contact Information

Trial Lead Organizations

Park Lane Clinic

Bernardo Rapoport, MD, MMed(IntMed), Protocol chair		Ph: 27-11-643-8056