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

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
DJ-927
Sponsored by
Daiichi Sankyo, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of New Mexico Cancer Research and Treatment Center
  • MD Anderson Cancer Center at University of Texas

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 7, 2004
Last Updated
May 15, 2012
Sponsor
Daiichi Sankyo, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00080834
Brief Title
DJ-927 as Second-Line Therapy in Treating Patients With Progressive Locally Advanced or Metastatic Colorectal Adenocarcinoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daiichi Sankyo, Inc.

4. Oversight

5. Study Description

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).
Detailed Description
OBJECTIVES: Primary 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 Determine the duration of response in patients treated with this drug. Determine the time to tumor progression in patients treated with this drug. Determine the median survival time in patients treated with this drug. Determine the quantitative and qualitative toxic effects of this drug in these patients. Determine the pharmacokinetics of this drug in these patients. 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. PROJECTED ACCRUAL: A total of 56-62 patients (28-31 per stratum) will be accrued for this study within 12 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
DJ-927

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Cheverton, MD, ChB, MMED, RadT
Organizational Affiliation
Daiichi Pharmaceuticals
Official's Role
Study Chair
Facility Information:
Facility Name
University of New Mexico Cancer Research and Treatment Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131-5636
Country
United States
Facility Name
MD Anderson Cancer Center at University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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.
Results Reference
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DJ-927 as Second-Line Therapy in Treating Patients With Progressive Locally Advanced or Metastatic Colorectal Adenocarcinoma

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