Gastric CancerPhase 2NCT00062257
Irofulven in Treating Patients With Recurrent or Metastatic Gastric Cancer
A Phase 2 study testing irofulven in people with Gastric Cancer, run by Cancer Therapeutics Research Group at 6 sites in 4 countries.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as irofulven, use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well irofulven works in treating patients with recurrent or metastatic gastric cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- irofulven
- How many people
- Not given
- Where
- 6 sitesin 4 countries
- Study dates
- Jun 2003to Sep 2006
- 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 or cytologically confirmed gastric adenocarcinoma
- Recurrent or metastatic disease
- Adenocarcinoma of the gastroesophageal junction eligible provided the majority of tumor bulk is below the junction
- Measurable disease
- At least 1 lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
- No known brain metastases
PATIENT CHARACTERISTICS:
Age
- Over 18
Performance status
- ECOG 0-2
Life expectancy
- More than 3 months
Hematopoietic
- WBC at least 3,000/mm^3
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- No active disseminated intravascular coagulation
Hepatic
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- AST/ALT no greater than 2.5 times ULN (5 times ULN for patients with liver metastases)
- Alkaline phosphatase no greater than 5 times ULN
Renal
- Creatinine no greater than 1.5 times ULN
Cardiovascular
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No prior allergic reaction attributed to compounds of similar chemical or biological composition to irofulven
- No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer
- No other uncontrolled concurrent illness that would preclude study participation
- No ongoing or active infection
- No psychiatric illness or social situation that would preclude study compliance
- Must have central or peripherally inserted central catheter
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent filgrastim (G-CSF), sargramostim (GM-CSF), or epoetin alfa
Chemotherapy
- No prior chemotherapy for recurrent or metastatic disease
- Prior adjuvant or neoadjuvant chemotherapy allowed provided disease relapsed more than 6 months after therapy
Endocrine therapy
- Not specified
Radiotherapy
- More than 4 weeks since prior radiotherapy and recovered
Surgery
- Not specified
Other
- No other concurrent investigational or commercial agents or therapies for the malignancy
- No concurrent combination antiretroviral therapy for HIV-positive patients
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
Singapore3 sites
Cancer Institute at National University Hospital
Singapore, 119074
Johns Hopkins - Singapore
Singapore, 119074
National Cancer Centre - Singapore
Singapore, 169610
Australia1 site
Sydney Cancer Centre at Royal Prince Alfred Hospital
Sydney, New South Wales, 2050
South Korea1 site
Yonsei Cancer Center at Yonsei University Medical Center
Seoul, 120-752
About this study
Official title: A Phase II Study of Irofulven as First Line Therapy in Recurrent or Metastatic Gastric Cancer
RATIONALE: Drugs used in chemotherapy, such as irofulven, use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well irofulven works in treating patients with recurrent or metastatic gastric cancer.
Read the detailed description
OBJECTIVES:
- Determine the response rate of patients with recurrent or metastatic gastric cancer treated with irofulven.
- Determine the toxicity profile of this drug in these patients.
- Determine the overall survival of patients treated with this drug.
OUTLINE: This is a non-randomized, open-label, multicenter study.
Patients receive irofulven IV over 30 minutes on days 1 and 8. Courses repeat every 3 weeks in the absence of disease progression, unacceptable toxicity, or static disease after 4 courses in the absence of clinical benefit.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 20-35 patients will be accrued for this study within 5-9 months.
- Conditions
- Gastric Cancer
- Being tested
- irofulven
- Keywords
- recurrent gastric cancer, stage IV gastric cancer, adenocarcinoma of the stomach
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
irofulvenDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2003 (estimated)
- Study startJun 2003
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric 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
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Cancer Therapeutics Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Winnie Yeo, Study chair, Prince of Wales Hospital, Shatin, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00062257
- Sponsor's protocol ID
- CTRG-G15/02
- Other IDs
- CDR0000304669, NCI-6041
- Status last verified
- Mar 2005
- First submitted
- 5 Jun 2003
- Last updated
- 15 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Irofulven as First Line Therapy in Recurrent or Metastatic Gastric Cancer
- ClinicalTrials.gov ID
- NCT00062257
- Acronym / sponsor ID
- CTRG-G15/02
- Conditions
- Gastric Cancer
- Keywords
- recurrent gastric cancer, stage IV gastric cancer, adenocarcinoma of the stomach
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Cancer Therapeutics Research GroupUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2003
- Study completion
- Sep 2006 (actual)
- First posted
- 6 Jun 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, such as irofulven, use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well irofulven works in treating patients with recurrent or metastatic gastric cancer.
Detailed description
OBJECTIVES:
- Determine the response rate of patients with recurrent or metastatic gastric cancer treated with irofulven.
- Determine the toxicity profile of this drug in these patients.
- Determine the overall survival of patients treated with this drug.
OUTLINE: This is a non-randomized, open-label, multicenter study.
Patients receive irofulven IV over 30 minutes on days 1 and 8. Courses repeat every 3 weeks in the absence of disease progression, unacceptable toxicity, or static disease after 4 courses in the absence of clinical benefit.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 20-35 patients will be accrued for this study within 5-9 months.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
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 |
|---|---|---|
| irofulven | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 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.
Winnie Yeo study chair
Prince of Wales Hospital, Shatin, Hong Kong
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing irofulven in people with Gastric Cancer, run by Cancer Therapeutics Research Group at 6 sites in 4 countries.
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: finished, as of the sponsor's last update on 15 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Singapore, Australia, Hong Kong, South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 15 May 2013.