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Nitrocamptothecin in Treating Patients With Locally Advanced or Metastatic Stomach Cancer That Cannot Be Removed During Surgery
This study is ongoing, but not recruiting participants.
First Received: June 2, 2000   Last Updated: July 23, 2008   History of Changes
Sponsored by: SuperGen
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005876
  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 locally advanced or metastatic stomach cancer that cannot be removed during surgery.


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

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders Stomach Cancer Surgery
Drug Information available for: Rubitecan
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Phase II Study of RFS 2000 (Rubitecan, 9-Nitro-Camptothecin, 9-NC) in Patients With Advanced Gastric Carcinoma

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005876

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

Additional Information:
No publications provided

Study ID Numbers: CDR0000067912, SUPERGEN-RFS2000-30, MDA-DM-99231
Study First Received: June 2, 2000
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00005876     History of Changes
Health Authority: United States: Federal Government

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

Study placed in the following topic categories:
Digestive System Neoplasms
Gastrointestinal Diseases
Esophageal Neoplasms
Esophageal Cancer
9-nitrocamptothecin
Camptothecin
Recurrence
Carcinoma
Digestive System Diseases
Stomach Diseases
Esophageal Disorder
Stomach Neoplasms
Head and Neck Neoplasms
Gastrointestinal Neoplasms
Stomach Cancer
Esophageal Diseases
Adenocarcinoma

Additional relevant MeSH terms:
Digestive System Neoplasms
Gastrointestinal Diseases
Antineoplastic Agents
Esophageal Neoplasms
9-nitrocamptothecin
Pharmacologic Actions
Neoplasms
Digestive System Diseases
Neoplasms by Site
Stomach Diseases
Therapeutic Uses
Stomach Neoplasms
Head and Neck Neoplasms
Gastrointestinal Neoplasms
Esophageal Diseases

ClinicalTrials.gov processed this record on May 07, 2009