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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Peter Cheverton, MD, ChB, MMED, RadT

Investigator Role:

Study Chair

Investigator Affiliation:

Daiichi Pharmaceuticals

Authority:

United States: Federal Government

Study ID:

CDR0000356034

NCT ID:

NCT00080834

Start Date:

February 2004

Completion Date:

August 2006

Related Keywords:

  • Colorectal Cancer
  • 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
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Colorectal Neoplasms
  • Colonic Neoplasms

Name

Location

University of New Mexico Cancer Research and Treatment CenterAlbuquerque, New Mexico  87131
MD Anderson Cancer Center at University of TexasHouston, Texas  77030-4009