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Nitrocamptothecin in Treating Patients With Locally Advanced or Metastatic Stomach Cancer That Cannot Be Removed During Surgery

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 June 2002 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
ClinicalTrials.gov Identifier:
First Posted: December 17, 2003
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)

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 locally advanced or metastatic stomach cancer that cannot be removed during surgery.

Condition Intervention Phase
Esophageal Cancer Gastric Cancer Drug: rubitecan Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase II Study of RFS 2000 (Rubitecan, 9-Nitro-Camptothecin, 9-NC) in Patients With Advanced Gastric Carcinoma

Resource links provided by NLM:

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

Study Start Date: April 2000
Detailed Description:

OBJECTIVES: I. Determine the objective response rate, progression-free survival, overall survival, and time to treatment failure in patients with unresectable locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction treated with oral nitrocamptothecin. II. Determine the toxicity of this regimen in these patients.

OUTLINE: Patients are stratified according to prior therapy (yes vs no). 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 week 8 may receive additional courses of therapy. Patients are followed every 3 months until death.

PROJECTED ACCRUAL: Approximately 21-55 patients will be accrued for this study.


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

DISEASE CHARACTERISTICS: Histologically proven unresectable locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction Limited prior immunotherapy or chemotherapy OR Failure after no more than 1 prior regimen of immunotherapy or chemotherapy (including chemotherapy as radiosensitizer) Primarily resistant or responsive disease but with subsequent progression No osseous metastasis as only site of disease Bidimensionally measurable or evaluable disease Mediastinal or hilar lymph nodes must be at least 1.5 cm in diameter by CT or MRI scan to be considered measurable No brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-1 OR Karnofsky 80-100% Life expectancy: At least 12 weeks Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 8 g/dL Hepatic: Bilirubin no greater than 1.5 mg/dL No Gilbert's syndrome Renal: Creatinine no greater than 1.5 mg/dL Calcium no greater than 12 mg/dL OR No symptomatic hypercalcemia under treatment Cardiovascular: No New York Heart Association class III or IV heart disease No angina, myocardial infarction, or congestive heart failure within the past 6 months Gastrointestinal: No intestinal obstruction No diarrhea (greater than 4 loose stools per day) Able to swallow Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No concurrent serious infection or nonmalignant medical illness that is uncontrolled or for which control may be jeopardized by complications of study therapy No history of seizures No psychiatric disorder that would preclude compliance No other malignancy within the past 5 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix No pre-existing cystitis

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics No concurrent immunotherapy including filgrastim (G-CSF) Chemotherapy: See Disease Characteristics No prior topoisomerase I inhibitors (e.g., irinotecan, topotecan, or aminocamptothecin) At least 4 weeks since other prior chemotherapy and recovered No other concurrent chemotherapy Endocrine therapy: No concurrent anticancer hormonal therapy Radiotherapy: No prior radiotherapy to major bone marrow-containing areas (e.g., pelvis, lumbar spine) No prior radiotherapy to sole indicator lesion At least 4 weeks since prior limited radiotherapy and recovered No concurrent radiotherapy Surgery: At least 1 week since prior minor surgery and recovered At least 3 weeks since prior major surgery and recovered Other: No concurrent phenytoin, phenobarbital, or other antiepileptic prophylaxis

  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): NCT00005876

United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
Astex Pharmaceuticals
Study Chair: Show-Li Sun, MD Astex Pharmaceuticals
  More Information

ClinicalTrials.gov Identifier: NCT00005876     History of Changes
Other Study ID Numbers: CDR0000067912
First Submitted: June 2, 2000
First Posted: December 17, 2003
Last Update Posted: December 4, 2013
Last Verified: June 2002

Keywords provided by National Cancer Institute (NCI):
stage III gastric cancer
stage IV gastric cancer
recurrent gastric cancer
stage III esophageal cancer
stage IV esophageal cancer
recurrent esophageal cancer
adenocarcinoma of the stomach
adenocarcinoma of the esophagus

Additional relevant MeSH terms:
Stomach Neoplasms
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Head and Neck Neoplasms
Esophageal Diseases
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action