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

NCT ID: NCT00077077

Last Updated: 2012-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-02-29
• Study Completion Date: 2006-01-31

Brief 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.

Detailed 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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

DJ-927

Intervention Type: DRUG

capecitabine

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daiichi Sankyo

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chris H. Takimoto, MD, PhD, FACP

Role:

Cancer Therapy and Research Center, Texas

Locations

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

Countries

United States

References

Saif MW, Sarantopoulos J, Patnaik A, Tolcher AW, Takimoto C, Beeram M. Tesetaxel, a new oral taxane, in combination with capecitabine: a phase I, dose-escalation study in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2011 Dec;68(6):1565-73. doi: 10.1007/s00280-011-1639-3. Epub 2011 May 6.

Reference Type: RESULT

PMID: 21547572 (View on PubMed)

Other Identifiers

DAIICHI-927A-PRT006

Identifier Type: -

Identifier Source: secondary_id

WSU-085503MP4F

Identifier Type: -

Identifier Source: secondary_id

CDR0000346368

Identifier Type: -

Identifier Source: org_study_id