RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients who have advanced or recurrent colorectal cancer.

Condition	Treatment or Intervention	Phase
recurrent colon cancer stage III colon cancer stage III rectal cancer Stage IV rectal cancer recurrent rectal cancer stage IV colon cancer	Procedure: chemotherapy  Drug: nitrocamptothecin	Phase II

Further Study Details: 

OBJECTIVES: I. Determine the objective response rate, overall survival, and time to disease progression after maximal response in patients with advanced or metastatic colorectal cancer treated with oral nitrocamptothecin. II. Determine the safety, toxicity, and pharmacokinetics of this regimen in these patients.

PROTOCOL OUTLINE: This is a multicenter study. Patients receive oral nitrocamptothecin on days 1-5. Treatment repeats every week for 8 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease after completion of course 8 may receive additional courses. Patients are followed every 3 months for 1 year or until death.

PROJECTED ACCRUAL: Approximately 14-45 patients will be accrued for this study over less than 1 year.

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically or cytologically proven colorectal cancer with failure or relapse after at least 1 prior fluorouracil based chemotherapy regimen for advanced disease OR metastatic disease within 6 months after completion of adjuvant therapy; No more than 1 prior fluorouracil based chemotherapy regimen for metastatic disease; Prior oral fluorouracil or combinations of other drugs with fluorouracil allowed; Prior adjuvant therapy with fluorouracil allowed and not counted as 1 regimen if given more than 1 year prior to study
• At least 1 bidimensionally measurable indicator lesion that has not been irradiated and has the following minimum dimensions: Skin nodule or superficial lymph node: 2 x 2 cm; Lung lesion surrounded by aerated lung: 1 x 1 cm by chest x-ray or at least 2 cm in 1 dimension by CT scan; Liver lesion, soft tissue mass, or lymph node: at least 2 cm in 1 dimension by CT scan or sonogram

--Prior/Concurrent Therapy--

• Biologic therapy: At least 2 weeks since prior immunotherapy and recovered; No concurrent filgrastim (G-CSF); No concurrent immunotherapy
• Chemotherapy: See Disease Characteristics; No prior nitrocamptothecin, irinotecan, or other camptothecin analog; At least 2 weeks since other prior chemotherapy and recovered; No other concurrent chemotherapy
• Endocrine therapy: No concurrent anticancer hormonal therapy
• Radiotherapy: See Disease Characteristics; At least 2 weeks since prior radiotherapy and recovered; No concurrent radiotherapy
• Surgery: At least 2 weeks since prior surgery and recovered; No scheduled major surgery within 8 weeks following initiation of treatment

--Patient Characteristics--

• Age: Not specified
• Performance status: ECOG 0-2
• Life expectancy: At least 8 weeks
• Hematopoietic: Granulocyte count greater than 1,500/mm3; Hemoglobin greater than 10 g/dL; Platelet count greater than 100,000/mm3
• Hepatic: SGOT and SGPT no greater than 3 times normal (no greater than 5 times normal if liver tumor present); Bilirubin no greater than 2 mg/dL
• Renal: Creatinine no greater than 2 mg/dL
• Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception during and for 6 months after study

California
      SuperGen, Incorporated, Dublin,  California,  94568,  United States

Study chairs or principal investigators

Show-Li Sun,  Study Chair,  SuperGen   

Study ID Numbers:  CDR0000067914; SUPERGEN-RFS2000-18; PCI-99-037
Record last reviewed:  February 2004
Last Updated:  October 13, 2004
Record first received:  June 2, 2000
ClinicalTrials.gov Identifier:  NCT00005877
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08