A Phase I Dose-Escalation Study of BIBH-1 in Patients With Advanced or Metastatic Fibroblast Activation Protein-Positive Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed unresectable, advanced and/or metastatic
disease: Colorectal cancer Measurable or evaluable disease Epidemiologically proven
fibroblast activation protein positive Failed or refused conventional treatment, and
unlikely to derive significant benefit from conventional treatments No active CNS
metastases No new or progressive lesions on CT scan, more than 3 months since treatment
(i.e., surgery or radiotherapy) for brain metastases, and/or not receiving mitomycin
Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: 18 and over Menopausal status: Not specified Performance
status: Karnofsky 70-100% Life expectancy: At least 4 months Hematopoietic: Absolute
granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: ALT/AST
no greater than 3 times upper limit of normal Bilirubin less than 2 mg/dL Renal:
Creatinine no greater than 2.0 mg/dL Other: Not pregnant or nursing Fertile patients must
use effective contraception No other serious illness No active infections requiring
antibiotics No bleeding disorders No other diseases that may potentially interfere with
obtaining accurate study results

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy No
prior murine, chimeric or humanized antibody and/or antibody fragment Chemotherapy: See
Disease Characteristics At least 4 weeks since prior chemotherapy (6 weeks for
nitrosoureas and mitomycin) Endocrine therapy: No concurrent systemic corticosteroids
(except for acute management of allergic-type events) No concurrent immunosuppressive
agents Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics
Recovered from surgery Other: At least 4 weeks since other prior investigational agents