NCT00077077

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Feb 2004

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 11, 2004

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
Last Updated

May 16, 2012

Status Verified

May 1, 2012

Enrollment Period

1.9 years

First QC Date

February 10, 2004

Last Update Submit

May 15, 2012

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

DJ-927DRUG
capecitabineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

Comprehensive Cancer Center at University of Alabama at Birmingham

Birmingham, Alabama, 35294-3300, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Cancer Therapy and Research Center

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

  • 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.

    PMID: 21547572RESULT

MeSH Terms

Interventions

tesetaxelCapecitabine

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Chris H. Takimoto, MD, PhD, FACP

    Cancer Therapy and Research Center, Texas

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2004

First Posted

February 11, 2004

Study Start

February 1, 2004

Primary Completion

January 1, 2006

Study Completion

January 1, 2006

Last Updated

May 16, 2012

Record last verified: 2012-05

Locations

US(3)