A Phase I Study Of The Combination Of Oral DJ-927 And Capecitabine In Patients With Advanced Solid Tumors

Study start date: February 1, 2004

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed solid tumor Locally advanced or metastatic disease Minimally pretreated No symptomatic brain metastases PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy At least 3 months Hematopoietic Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic SGOT and SGPT no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present) Bilirubin no greater than 1.5 times ULN Renal Creatinine no greater than 1.5 times ULN Gastrointestinal No prior chronic diarrhea No swallowing and/or malabsorption problems No diarrhea (excess of 2-3 stools/day above normal frequency in the past month) Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative No prior severe or life-threatening hypersensitivity reaction to a taxane or capecitabine No concurrent serious infection No neuropathy grade 2 or greater No other malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the cervix No other severe or uncontrolled underlying medical disease that would preclude study participation No psychiatric disorder that would preclude giving informed consent or study compliance PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent anticancer biologic therapy Chemotherapy Recovered from prior chemotherapy No other concurrent anticancer chemotherapy Endocrine therapy Not specified Radiotherapy Recovered from prior radiotherapy No concurrent anticancer radiotherapy Concurrent localized radiotherapy to a non-indicator lesion for pain relief is allowed provided other methods of pain control are ineffective Surgery At least 4 weeks since prior major surgery and recovered No prior major surgery in the stomach or small intestine Other At least 4 weeks since prior myelosuppressive therapy More than 28 days since prior investigational drugs (including analgesics and/or antiemetics) No other concurrent anticancer therapy No other concurrent anticancer cytotoxic therapy