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A Randomized Phase II Study of Two Shcedules of Ro 31-7453 in Patients With Metastatic (Dukes' D) Colorectal Carcinoma (CRC) Who Have Failed Both Fluoropyrimidine and Irinotecan Chemotherapy


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

Thank you

Trial Information

A Randomized Phase II Study of Two Shcedules of Ro 31-7453 in Patients With Metastatic (Dukes' D) Colorectal Carcinoma (CRC) Who Have Failed Both Fluoropyrimidine and Irinotecan Chemotherapy


OBJECTIVES:

- Compare the objective disease rate of patients with recurrent or refractory metastatic
colorectal cancer treated with two dose schedules of Ro 31-7453.

- Compare the safety and tolerability of these regimens in these patients.

- Compare the response duration in patients treated with these regimens.

- Compare the time to progression and time to treatment failure in patients treated with
these regimens.

- Determine the pharmacokinetic profiles of Ro 31-7453 and its major metabolites in these
patients.

- Compare the overall survival of patients treated with these regimens.

OUTLINE: This is a randomized, open label, multicenter study. Patients are randomized to one
of two treatment arms.

- Arm I: Patients receive oral Ro 31-7453 twice daily on days 1-4. Treatment repeats
every 21 days in the absence of disease progression or unacceptable toxicity.

- Arm II: Patients receive oral Ro 31-7453 twice daily on days 1-14. Treatment repeats
every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed at 28 days and then every 3 months.

PROJECTED ACCRUAL: Approximately 160 patients (49 per treatment arm plus 61 additional
patients in the arm determined to be most effective) will be accrued for this study within 1
year.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed metastatic adenocarcinoma of the colon or rectum

- Bidimensionally measurable disease

- At least 2.0 x 2.0 cm

- Failed prior fluoropyrimidine and irinotecan chemotherapy in adjuvant or metastatic
setting

- Must have had disease progression while receiving chemotherapy OR

- If received fluorouracil with or without irinotecan in adjuvant setting, must
also have failed therapy with these agents in metastatic setting (unless
manifesting metastatic disease during adjuvant therapy)

- No known CNS metastases

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 70-100%

Life expectancy:

- Not specified

Hematopoietic:

- Hemoglobin at least 9 g/dL

- Absolute neutrophil count at least 1,500/mm^3

- WBC at least 3,000/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- AST/ALT no greater than 2.5 times ULN (5 times ULN if liver metastases present)

- Alkaline phosphatase no greater than 2.5 ULN (5 times ULN if bone or liver metastases
present)

Renal:

- Creatinine no greater than 1.5 times ULN

Cardiovascular:

- No New York Heart Association class III or IV congestive heart failure

- No myocardial infarction within the past 6 months

Gastrointestinal:

- No bowel obstruction

- No active uncontrolled malabsorption syndrome

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No active infection

- No other prior malignancy within the past 5 years except carcinoma in situ of the
cervix or non-melanoma skin cancer

- No other active cancers, including stable disease on adjuvant therapy

- No other medical condition that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- See Chemotherapy

- At least 2 weeks since prior biologic therapy and recovered

Chemotherapy:

- See Disease Characteristics

- No more than 2 prior cytotoxic chemotherapy regimens for metastatic disease

- Monoclonal antibody (MOAB) therapy and antiangiogenic agents not included as prior
cytotoxic chemotherapy

- At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and
recovered

Endocrine therapy:

- Not specified

Radiotherapy:

- At least 3 weeks since prior radiotherapy and recovered

Surgery:

- No prior total gastrectomy

Other:

- No other concurrent investigational agents

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Sunil Sharma, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

00-139

NCT ID:

NCT00016250

Start Date:

December 2000

Completion Date:

June 2002

Related Keywords:

  • Colorectal Cancer
  • stage IV colon cancer
  • stage IV rectal cancer
  • recurrent colon cancer
  • recurrent rectal cancer
  • adenocarcinoma of the colon
  • adenocarcinoma of the rectum
  • Colorectal Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021