ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00080834
Recruitment Status : Completed
First Posted : April 8, 2004
Last Update Posted : May 16, 2012
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

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).


Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: DJ-927 Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : February 2004
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2006




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00080834


Locations
United States, New Mexico
University of New Mexico Cancer Research and Treatment Center
Albuquerque, New Mexico, United States, 87131-5636
United States, Texas
MD Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
Daiichi Sankyo, Inc.
Investigators
Study Chair: Peter Cheverton, MD, ChB, MMED, RadT Daiichi Pharmaceuticals

Publications of Results:
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.

Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT00080834     History of Changes
Other Study ID Numbers: CDR0000356034
DAIICHI-927A-PRT004
MDA-2003-0749
First Posted: April 8, 2004    Key Record Dates
Last Update Posted: May 16, 2012
Last Verified: May 2012

Keywords provided by Daiichi Sankyo, Inc.:
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

Additional relevant MeSH terms:
Colorectal Neoplasms
Adenocarcinoma
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type