Pancreatic CancerPhase 3NCT00005871
Nitrocamptothecin or Fluorouracil in Treating Patients With Recurrent or Refractory Pancreatic Cancer
A Phase 3 study testing fluorouracil and rubitecan in people with Pancreatic 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. It is not yet known whether nitrocamptothecin is more effective than fluorouracil for pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- fluorouracil and rubitecan
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Nov 1998to not given
- Phase
- Phase 3
- 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 or cytologically confirmed recurrent or refractory adenocarcinoma of the pancreas Must have received prior gemcitabine and progressed
PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Karnofsky 50-100% Life expectancy: At least 2 months Hematopoietic: Granulocyte count greater than 1,500/mm3 Hemoglobin at least 9 g/dL Platelet count greater than 100,000/mm3 Hepatic: SGOT and SGPT no greater than 3 times upper limit of normal (ULN) (no greater than 5 times ULN if tumor involves liver) Bilirubin no greater than 2.0 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: See Disease Characteristics At least 2 weeks since prior gemcitabine and recovered No prior chemotherapy except gemcitabine No other concurrent chemotherapy Endocrine therapy: No concurrent corticosteroids or hormones Radiotherapy: No concurrent radiotherapy Surgery: At least 2 weeks since prior major surgery No major surgery within 8 weeks following initiation of study treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase III Randomized Study of RFS 2000 (9-Nitro-Camptothecin, 9-NC) Versus 5-Fluorouracil (5-FU) in Pancreatic Cancer Patients That Have Progressive Disease Following Gemcitabine HCl Treatment
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether nitrocamptothecin is more effective than fluorouracil for pancreatic cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of nitrocamptothecin with that of fluorouracil in treating patients who have recurrent or refractory pancreatic cancer and who have been treated previously with gemcitabine.
Read the detailed description
OBJECTIVES: I. Compare survival of patients with recurrent or refractory pancreatic cancer after treatment with nitrocamptothecin versus fluorouracil. II. Compare the clinical benefit and objective response rate to these treatment regimens in these patients. III. Compare and evaluate time to treatment failure in these patients with these treatment regimens. IV. Compare the toxicities of these treatment regimens in these patients.
OUTLINE: This is a randomized, open label, multicenter study. Patients are randomized to one of two treatment arms. Arm I: Patients receive nitrocamptothecin orally on days 1-5. Arm II: Patients receive fluorouracil IV over 30 minutes on day 1. Treatment repeats weekly for 8 courses in the absence of disease progression or unacceptable toxicity. Patients with tumor regression or stabilization may receive additional courses of treatment. Patients with disease progression or unacceptable toxicity may crossover to the alternate treatment arm. Patients are followed every 3 months for one year.
PROJECTED ACCRUAL: A total of 400 patients (200 per treatment arm) will be accrued for this study within 15 months.
- Conditions
- Pancreatic Cancer
- Being tested
- fluorouracil, rubitecan
- Keywords
- recurrent pancreatic cancer, adenocarcinoma of the pancreas
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluorouracilDrug
rubitecanDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2004 (estimated)
- Study startNov 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
Sponsor and investigators
- Lead sponsor
- Astex Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Lawrence A. Romel, MS, Study chair, Astex Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005871
- Sponsor's protocol ID
- CDR0000067907
- Other IDs
- SUPERGEN-RFS2000-06, PCI-99-001
- Status last verified
- Jun 2007
- 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
- Phase III Randomized Study of RFS 2000 (9-Nitro-Camptothecin, 9-NC) Versus 5-Fluorouracil (5-FU) in Pancreatic Cancer Patients That Have Progressive Disease Following Gemcitabine HCl Treatment
- ClinicalTrials.gov ID
- NCT00005871
- Acronym / sponsor ID
- CDR0000067907
- Conditions
- Pancreatic Cancer
- Keywords
- recurrent pancreatic cancer, adenocarcinoma of the pancreas
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Astex Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 1998
- First posted
- 3 May 2004 (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. It is not yet known whether nitrocamptothecin is more effective than fluorouracil for pancreatic cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of nitrocamptothecin with that of fluorouracil in treating patients who have recurrent or refractory pancreatic cancer and who have been treated previously with gemcitabine.
Detailed description
OBJECTIVES: I. Compare survival of patients with recurrent or refractory pancreatic cancer after treatment with nitrocamptothecin versus fluorouracil. II. Compare the clinical benefit and objective response rate to these treatment regimens in these patients. III. Compare and evaluate time to treatment failure in these patients with these treatment regimens. IV. Compare the toxicities of these treatment regimens in these patients.
OUTLINE: This is a randomized, open label, multicenter study. Patients are randomized to one of two treatment arms. Arm I: Patients receive nitrocamptothecin orally on days 1-5. Arm II: Patients receive fluorouracil IV over 30 minutes on day 1. Treatment repeats weekly for 8 courses in the absence of disease progression or unacceptable toxicity. Patients with tumor regression or stabilization may receive additional courses of treatment. Patients with disease progression or unacceptable toxicity may crossover to the alternate treatment arm. Patients are followed every 3 months for one year.
PROJECTED ACCRUAL: A total of 400 patients (200 per treatment arm) will be accrued for this study within 15 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
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 |
|---|---|---|
| fluorouracil | Drug | – |
| 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.
Lawrence A. Romel, MS 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 3 study testing fluorouracil and rubitecan in people with Pancreatic 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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.