Ro 31-7453 in Treating Patients With Recurrent or Refractory Metastatic Colorectal Cancer

• Status: Completed
• Trial end date: 2002-06-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Randomized phase II trial to compare the effectiveness of two different regimens of Ro 31-7453 in treating patients who have recurrent or refractory metastatic colorectal cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: National Cancer Institute (NCI)

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