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Nitrocamptothecin in Treating Patients With Advanced or Recurrent Colorectal Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2002 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00005877
First Posted: February 12, 2004
Last Update Posted: December 4, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Cancer Institute (NCI)
  Purpose

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 Intervention Phase
Colorectal Cancer Drug: rubitecan Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: September 1999
Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005877


Locations
United States, California
SuperGen, Incorporated
Dublin, California, United States, 94568
Sponsors and Collaborators
Astex Pharmaceuticals
Investigators
Study Chair: Show-Li Sun, MD Astex Pharmaceuticals
  More Information

ClinicalTrials.gov Identifier: NCT00005877     History of Changes
Other Study ID Numbers: CDR0000067914
SUPERGEN-RFS2000-18
PCI-99-037
First Submitted: June 2, 2000
First Posted: February 12, 2004
Last Update Posted: December 4, 2013
Last Verified: April 2002

Keywords provided by National Cancer Institute (NCI):
stage III colon cancer
stage IV colon cancer
stage III rectal cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Rubitecan
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action


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