Diffuse Adenocarcinoma of the StomachPhase 2NCT00103324
S0413 Lapatinib in Treating Patients With Locally Advanced or Metastatic Stomach Cancer
A Phase 2 study testing lapatinib ditosylate and laboratory biomarker analysis in people with Diffuse Adenocarcinoma of the Stomach and Intestinal Adenocarcinoma of the Stomach, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This phase II trial is studying how well lapatinib works in treating patients with locally advanced or metastatic stomach cancer. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Adenocarcinoma of the Stomach, Intestinal Adenocarcinoma of the Stomach, Mixed Adenocarcinoma of the Stomach
- What is being tested?
- lapatinib ditosylate and laboratory biomarker analysis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2004to May 2007
- 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
Who may be able to join
- Patients must have cytologically or pathologically verified diagnosis of gastric cancer; patients must have locally advanced or distant metastatic disease (either recurrent or at primary diagnosis) that is not surgically curable
- The pathologic confirmation of gastric cancer may be made from the metastatic site; biopsy of the primary tumor is not necessary; patients with pathologic confirmation of cancer from a metastatic site, along with clinical documentation of gastric involvement and no evidence of another primary are also eligible
- Eligible pathologic type: patients may have any histological subtype including adenocarcinoma NOS, papillary carcinoma, adenocarcinoma, intestinal type, clear cell adenocarcinoma, mucinous carcinoma, signet ring cell carcinoma, undifferentiated carcinoma, carcinoma NOS; patients must not have carcinoid tumors or sarcomas
- Patients must have measurable disease; x-rays, scans, or physical examinations for measurable disease must have been completed within 28 days prior to registration; x-rays, scans or physical examinations for non-measurable disease must have been completed within 42 days prior to registration,; all disease must be assessed
- Patients must be willing to have specimens submitted; the paraffin embedded specimens must be available for submission
- Patients may have had prior surgery for their gastric cancer; patients must be at least 2 weeks beyond surgery, and recovered from all effects of surgery
Show all 27Show fewer
- Patients may have received prior chemotherapy, hormonal therapy, immunotherapy, radiation or chemoradiotherapy as neoadjuvant or adjuvant treatment but this must have been completed at least 6 months prior to documented recurrence or metastatic disease; patients must not have received previous treatment for metastatic disease
- If patient received radiation therapy, the site of measurable disease must be outside of the radiation field
- Patients must not have had prior therapy with EGFR targeting therapies
- Patients must have a Zubrod performance status of 0-1
- Leukocytes >= 3,000/mcl
- Platelets >= 100,000/mcl
- AGC >= 1,500/mcl
- Serum transaminase (SGOT or SGPT) =< 2.5 x IULN; patients with liver metastases must have SGOT/SGPT =< 5 x IULN
- Bilirubin =< IULN
- Serum creatinine =< IULN OR measured creatinine clearance > 60 mL/min OR estimated creatinine clearance> 60 mL/min
- Patients must have cardiac ejection fraction within the institutional range of normal as measured by echocardiogram or MUGA scan; note that baseline and on treatment scans should be performed using the same modality and preferably at the same institution
- Patients must either be able to swallow and/or receive enteral medications via gastrostomy feeding tube; patients with intractable nausea or vomiting are not eligible; patients with GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, or uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis) are not eligible
- Patients must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to GW572016
- There must be no plans for the patient to receive concurrent chemotherapy, hormonal therapy, radiotherapy, immunotherapy or any other type of therapy for treatment of their cancer while on this protocol
- HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with GW572016
- Pregnant or nursing women are not eligible because of the risk of fetal harm; nursing women may participate only if nursing is discontinued, due to the possibility of harm to nursing infants from this treatment regimen; women/men of reproductive potential must have agreed to use an effective contraceptive method
- No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in remission or any other cancer from which the patient has been disease-free for 5 years
- If day 28 or 42 falls on a weekend or holiday, the limit may be extended to the next working day
- In calculating days of tests and measurements, the day a test or measurement is done is considered day 0; therefore, if a test is done on a Monday, the Monday four weeks later would be considered day 28; this allows for efficient patient scheduling without exceeding the guidelines
- All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
- At the time of patient registration, the treating institution's name and ID number must be provided to the Statistical Center in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the data base
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of GW572016 (NSC-727989) as First Line Therapy in Patients With Advanced or Metastatic Gastric Cancer
This phase II trial is studying how well lapatinib works in treating patients with locally advanced or metastatic stomach cancer. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
Read the detailed description
PRIMARY OBJECTIVES:
- To assess the confirmed response (complete and partial) probability in patients with advanced/metastatic gastric cancer treated with GW572016.
II. To assess the time to treatment failure and overall survival in this group of patients.
III. To assess the qualitative and quantitative toxicities associated with this regimen.
IV. To assess, in a preliminary manner, the relationship of protein expression and gene expression of EGFR, HER2 and markers of angiogenesis with clinical outcomes in patients treated with GW572016.
OUTLINE: This is a multicenter study.
Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for up to 2 years.
- Conditions
- Diffuse Adenocarcinoma of the Stomach, Intestinal Adenocarcinoma of the Stomach, Mixed Adenocarcinoma of the Stomach, Recurrent Gastric Cancer, Stage III Gastric Cancer, Stage IV Gastric Cancer
- Being tested
- lapatinib ditosylate, laboratory biomarker analysis
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lapatinib ditosylateDrug
Also called GSK572016, GW-572016, GW2016, Lapatinib
Given orally
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: lapatinib ditosylate; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirmed response probability (complete and partial)
Measured: Up to 2 years
Secondary outcomes (2)
Time to treatment failure
Measured: From the date of registration to the date of first observation of progressive disease, death due to any cause, symptomatic deterioration, or early discontinuation of treatment, assessed up to 2 years
Overall survival
Measured: From date of registration to date of death due to any cause, assessed up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2005 (estimated)
- Study startDec 2004
- Primary completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Adenocarcinoma of the StomachStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Syma Iqbal, Principal investigator, SWOG Cancer Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00103324
- Sponsor's protocol ID
- NCI-2012-03180
- Other IDs
- S0413, U01CA32102, CDR0000409575
- Status last verified
- Jan 2013
- First submitted
- 7 Feb 2005
- Last updated
- 17 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of GW572016 (NSC-727989) as First Line Therapy in Patients With Advanced or Metastatic Gastric Cancer
- ClinicalTrials.gov ID
- NCT00103324
- Acronym / sponsor ID
- NCI-2012-03180
- Conditions
- Diffuse Adenocarcinoma of the Stomach, Intestinal Adenocarcinoma of the Stomach, Mixed Adenocarcinoma of the Stomach, Recurrent Gastric Cancer, Stage III Gastric Cancer, Stage IV Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Dec 2004
- Primary completion
- May 2007 (actual)
- First posted
- 8 Feb 2005 (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.
This phase II trial is studying how well lapatinib works in treating patients with locally advanced or metastatic stomach cancer. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
Detailed description
PRIMARY OBJECTIVES:
- To assess the confirmed response (complete and partial) probability in patients with advanced/metastatic gastric cancer treated with GW572016.
II. To assess the time to treatment failure and overall survival in this group of patients.
III. To assess the qualitative and quantitative toxicities associated with this regimen.
IV. To assess, in a preliminary manner, the relationship of protein expression and gene expression of EGFR, HER2 and markers of angiogenesis with clinical outcomes in patients treated with GW572016.
OUTLINE: This is a multicenter study.
Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for up to 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: lapatinib ditosylate, Other: laboratory biomarker analysisPatients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Patients must have cytologically or pathologically verified diagnosis of gastric cancer; patients must have locally advanced or distant metastatic disease (either recurrent or at primary diagnosis) that is not surgically curable
- Patients must have measurable disease; x-rays, scans, or physical examinations for measurable disease must have been completed within 28 days prior to registration; x-rays, scans or physical examinations for non-measurable disease must have been completed within 42 days prior to registration,; all disease must be assessed
- Patients must be willing to have specimens submitted; the paraffin embedded specimens must be available for submission
- Patients may have had prior surgery for their gastric cancer; patients must be at least 2 weeks beyond surgery, and recovered from all effects of surgery
- Patients may have received prior chemotherapy, hormonal therapy, immunotherapy, radiation or chemoradiotherapy as neoadjuvant or adjuvant treatment but this must have been completed at least 6 months prior to documented recurrence or metastatic disease; patients must not have received previous treatment for metastatic disease
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| lapatinib ditosylateAlso: GSK572016, GW-572016, GW2016, LapatinibGiven orally | Drug | Treatment |
| laboratory biomarker analysisCorrelative studies | Other | Treatment |
Primary outcome
Confirmed response probability (complete and partial)
Time frame: Up to 2 years
2 secondary outcomes
Time to treatment failure
Time frame: From the date of registration to the date of first observation of progressive disease, death due to any cause, symptomatic deterioration, or early discontinuation of treatment, assessed up to 2 years
Overall survival
Time frame: From date of registration to date of death due to any cause, assessed up to 2 years
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 17 Jan 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.
Syma Iqbal principal investigator
SWOG Cancer Research Network
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 lapatinib ditosylate and laboratory biomarker analysis in people with Diffuse Adenocarcinoma of the Stomach and Intestinal Adenocarcinoma of the Stomach, run by National Cancer Institute (NCI) 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?
The sponsor lists 27 inclusion and 0 exclusion criteria. 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 17 Jan 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?
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.
What does the primary outcome measure?
Confirmed response probability (complete and partial) (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
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 17 Jan 2013.