Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	Pharmaceutical / Industry	DAIICHI-927A-PRT004 MDA-2003-0749, NCT00080834

Objectives

Primary

1. Determine the objective tumor response rate in patients with progressive locally advanced or metastatic adenocarcinoma of the colon or rectum treated with DJ-927 as second-line treatment.

Secondary

1. Determine the duration of response in patients treated with this drug.
2. Determine the time to tumor progression in patients treated with this drug.
3. Determine the median survival time in patients treated with this drug.
4. Determine the quantitative and qualitative toxic effects of this drug in these patients.
5. Determine the pharmacokinetics of this drug in these patients.

Entry Criteria

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

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

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• At least 3 months

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³

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

Expected Enrollment

A total of 56-62 patients (28-31 per stratum) will be accrued for this study within 12 months.

Outline

This is an open-label, multicenter study. Patients are stratified according to prior first-line treatment regimen (irinotecan-containing vs oxaliplatin-containing).

Patients receive oral DJ-927* on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

 [Note: *Patients receive 1 of 2 selected doses to confirm the previously established maximum tolerated dose]

Patients are followed every 3 months.

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.

Trial Contact Information

Trial Lead Organizations

Daiichi Sankyo, Incorporated

Peter Cheverton, MD, ChB, MMED, RadT, Protocol chair		Ph: 44-171-936-2850

Registry Information
Official Title		A Phase II Study Of Oral DJ-927 Administered As A Single Dose Every Three Weeks To Patients With Advanced Or Metastatic Adenocarcinoma Of The Colon Or Rectum
Trial Start Date		2004-02-10
Registered in ClinicalTrials.gov		NCT00080834
Date Submitted to PDQ		2004-02-10
Information Last Verified		2005-04-29

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