DJ-927 and Capecitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors

Daiichi Sankyo

Overview

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Masking

NONE

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Interventions

DJ-927DRUG

capecitabineDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Comprehensive Cancer Center at University of Alabama at Birmingham

Birmingham, Alabama, United States

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Cancer Therapy and Research Center

San Antonio, Texas, United States

Data from ClinicalTrials.gov

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