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Phase II and Pharmacokinetic Study of RFS 2000 (9-Nitro-Camptothecin, 9-NC) in Patients With Advanced Colorectal Cancer Who Have Failed Previous 5-FU Based Chemotherapy


Phase 2
N/A
N/A
Open (Enrolling)
Both
Colorectal Cancer

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Trial Information

Phase II and Pharmacokinetic Study of RFS 2000 (9-Nitro-Camptothecin, 9-NC) in Patients With Advanced Colorectal Cancer Who Have Failed Previous 5-FU Based Chemotherapy


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.

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.

Inclusion 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

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

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Show-Li Sun, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Astex Pharmaceuticals

Authority:

United States: Federal Government

Study ID:

CDR0000067914

NCT ID:

NCT00005877

Start Date:

September 1999

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • stage III colon cancer
  • stage IV colon cancer
  • stage III rectal cancer
  • stage IV rectal cancer
  • recurrent colon cancer
  • recurrent rectal cancer
  • Colorectal Neoplasms

Name

Location

SuperGen, IncorporatedDublin, California  94568