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

Daiichi Sankyo

Status and phase: Completed; Phase 1

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Treatments: Drug: DJ-927; Drug: capecitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00077077

CDR0000346368

DAIICHI-927A-PRT006

WSU-085503MP4F

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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