Nitrocamptothecin in Treating Patients With Advanced or Recurrent Colorectal Cancer

NCT00005877 | Unknown Phase 2

• 3 other identifiers: CDR0000067914SUPERGEN-RFS2000-18PCI-99-037
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Cancer

Keywords

stage III colon cancer; stage IV colon cancer; stage III rectal cancer; stage IV rectal cancer; recurrent colon cancer; recurrent rectal cancer

Interventions

rubitecan DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Astex Pharmaceuticals, Inc.: lead

Study Sites (1)

SuperGen, Incorporated

Dublin, California, 94568, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

rubitecan

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Show-Li Sun, MD

  Astex Pharmaceuticals, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 2, 2000
• First Posted: February 12, 2004
• Study Start: September 1, 1999
• Last Updated: December 4, 2013

Record last verified: 2002-04

Locations

US (1)