Table 2 Anti tumour activity by dose levels

From: Phase Ib study of NGR–hTNF, a selective vascular targeting agent, administered at low doses in combination with doxorubicin to patients with advanced solid tumours

DL

Pt. no.

Gender/age (yrs)

Primary tumour

Previous no. of regimens

Previous anthracyclines/ best response

NGR–TNF dose ( μ g m −2 )/no. of cycles

Doxorubicin dose (mg m −2 )/no. of cycles

Best response

Duration of PR or SD (months)

1

1

M/58

Head and neck

2

No

0.2/4

60/4

SD

3

 

2

F/42

Cervix

6

No

0.2/6

60/6

SD

4.7

 

3

F/59

Colon

2

No

0.2/2

60/2

PD

2

4

F/58

Ovarian

5

Yes/SD

0.2/8

75/5

SDa

6.4

 

5

M/56

Ampulla of Vater

1

No

0.2/15

75/8

SD

11.9

 

6

F/31

Thymoma

1

Yes/PD

0.2/4

75/4

SD

2.9

3

7

M/58

Thymoma

1

Yes/PD

0.4/3

75/3

PDb

 

8

M/62

SCLC

2

Yes/PD

0.4/4

75/4

SD

3.5

 

9

M/83

Angiosarcoma

3

Yes/PD

0.4/6

75/4

SD

4.2

4

10

M/59

Oesophageal

2

No

0.8/8

75/6

PR

4.7

 

11

M/54

Chordoma

5

Yes/PD

0.8/9

75/3

SD

8.2

 

12

F/54

Sarcoma

2

Yesc

0.8/8

75/3

SD

6.5

5

13

M/51

Hepatocellular

1

Yesd

1.6/8

75/6

SD

6.7

 

14

M/44

Melanoma

2

No

1.6/2

75/2

PD

 

15

M/69

Sarcoma

2

Yes/PD

1.6/2

75/2

PDb

  1. Abbreviations: DL, dose level; F, female; M, male; NGR–TNF, asparagine–glycine–arginine–tumour necrosis factor; PR, partial response; SCLC, small cell lung cancer, PD, progressive disease; SD, stable disease.
  2. aPatient with radiologically documented partial response after the sixth cycle.
  3. bPatient with radiologically documented stable disease at first tumour restaging carried out after two cycles.
  4. cPatient treated with epirubicin in adjuvant setting.
  5. dPatient with radiologically documented stable disease for whom epirubicin treatment was stopped after two cycles because of marked increase of alpha-fetoprotein.