Esophageal CancerPhase 2NCT00005876
Nitrocamptothecin in Treating Patients With Locally Advanced or Metastatic Stomach Cancer That Cannot Be Removed During Surgery
A Phase 2 study testing rubitecan in people with Esophageal Cancer and Gastric Cancer, run by Astex Pharmaceuticals, Inc. at 1 site in United States.
Trial 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 locally advanced or metastatic stomach cancer that cannot be removed during surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer, Gastric Cancer
- What is being tested?
- rubitecan
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Apr 2000to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
About this study
Official title: A Phase II Study of RFS 2000 (Rubitecan, 9-Nitro-Camptothecin, 9-NC) in Patients With Advanced Gastric Carcinoma
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.
Read the 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.
- Conditions
- Esophageal Cancer, Gastric Cancer
- Being tested
- rubitecan
- Keywords
- 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
- Medical subject headings
- Esophageal Neoplasms, Stomach Neoplasms, Adenocarcinoma Of Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rubitecanDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2003 (estimated)
- Study startApr 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Astex Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Show-Li Sun, MD, Study chair, Astex Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005876
- Sponsor's protocol ID
- CDR0000067912
- Other IDs
- SUPERGEN-RFS2000-30, MDA-DM-99231
- Status last verified
- Jun 2002
- First submitted
- 2 Jun 2000
- Last updated
- 4 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of RFS 2000 (Rubitecan, 9-Nitro-Camptothecin, 9-NC) in Patients With Advanced Gastric Carcinoma
- ClinicalTrials.gov ID
- NCT00005876
- Acronym / sponsor ID
- CDR0000067912
- Conditions
- Esophageal Cancer, Gastric Cancer
- Keywords
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Astex Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2000
- First posted
- 17 Dec 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rubitecan | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Show-Li Sun, MD study chair
Astex Pharmaceuticals, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing rubitecan in people with Esophageal Cancer and Gastric Cancer, run by Astex Pharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2013.