dj-927 and capecitabine in treating patients with locally advanced or metastatic solid tumors

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Summary: rationale: drugs used in chemotherapy, such as dj-927 and capecitabine, use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells. purpose: this phase i trial is studying the side effects and best dose of dj-927 and capecitabine in treating patients with locally advanced or metastatic solid tumors.

objectives: primary * determine the maximum tolerated dose of dj-927 and capecitabine in patients with locally advanced or metastatic solid tumors. * determine the dose-limiting and non-dose-limiting toxic effects of this regimen in these patients. secondary * determine the toxicity profile of this regimen in these patients. * determine the possible pharmacokinetic interactions of this regimen in these patients. * determine the antitumor activity of this regimen in these patients. outline: this is an open-label, dose-escalation, nonrandomized, multicenter study. * course 1: patients receive oral dj-927 once on day 1 and oral capecitabine once on days 0 and 1 and twice daily on days 2-14. * course 2: patients receive dj-927 as in course 1 and oral capecitabine twice daily on days 2-15. * course 3 and all subsequent courses: patients receive dj-927 as in course 1 and oral capecitabine twice daily on days 1-14. all courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. cohorts of 3-6 patients receive escalating doses of dj-927 and capecitabine until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. a minimum of 6 patients receive treatment at the mtd. patients are followed every 3 months. projected accrual: a total of 30-40 patients will be accrued for this study within 18 months.

Eligibility criteria:
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

Keywords: unspecified adult solid tumor, protocol specific