DJ-927 as Second-Line Therapy in Treating Patients With Progressive Locally Advanced or Metastatic Colorectal Adenocarcinoma

NCT00080834 | Completed Phase 2

• 3 other identifiers: CDR0000356034DAIICHI-927A-PRT004MDA-2003-0749
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as DJ-927, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well DJ-927 works as second-line therapy in treating patients with progressive locally advanced or metastatic colorectal adenocarcinoma (cancer).

Conditions

Colorectal Cancer

Keywords

adenocarcinoma of the colon; adenocarcinoma of the rectum; recurrent colon cancer; recurrent rectal cancer; stage III colon cancer; stage IV colon cancer; stage III rectal cancer; stage IV rectal cancer

Interventions

DJ-927 DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the colon or rectum * Progressive locally advanced or metastatic disease * Received 1 prior irinotecan- or oxaliplatin-containing regimen * At least 1 measurable lesion * Target lesion must be outside field of prior radiotherapy * 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 ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * ALT and AST ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present) * Bilirubin ≤ 1.5 times ULN Renal * Creatinine ≤ 1.5 times ULN Gastrointestinal * No difficulty with swallowing * No malabsorption * No diarrhea (excess of 2-3 stools/day above normal frequency) within the past month * No history of chronic diarrhea Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative * No concurrent serious infection * No other concurrent severe or uncontrolled underlying medical condition that would preclude study participation * No neuropathy ≥ grade 2 * No history of any severe or life-threatening hypersensitivity reaction * No psychiatric disorder that would preclude study compliance * No other malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent biologic therapy Chemotherapy * See Disease Characteristics * At least 4 weeks since prior myelosuppressive chemotherapy and recovered * No other concurrent chemotherapy Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * At least 4 weeks since prior radiotherapy and recovered * No concurrent radiotherapy * Localized radiotherapy to non-indicator lesions for pain relief 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 * More than 28 days since prior investigational agents (including analgesics and/or antiemetics) * No other concurrent anticancer therapy * No other concurrent cytotoxic therapy * No concurrent grapefruit products

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

Sponsors & Collaborators

• Daiichi Sankyo: lead

Study Sites (2)

University of New Mexico Cancer Research and Treatment Center

Albuquerque, New Mexico, 87131-5636, United States

Location

MD Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

Related Publications (1)

• Rhee JM, Lee FC, Saif MW, et al.: Phase II trial of DJ-927 as a second-line treatment for colorectal cancer demonstrates objective responses. [Abstract] J Clin Oncol 23 (Suppl 16): A-3654, 284s, 2005.

  RESULT

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

tesetaxel

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Peter Cheverton, MD, ChB, MMED, RadT

  Daiichi Pharmaceuticals

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2004
• First Posted: April 8, 2004
• Study Start: February 1, 2004
• Primary Completion: August 1, 2006
• Study Completion: August 1, 2006
• Last Updated: May 16, 2012

Record last verified: 2012-05

Locations

US (2)