Stage III Gastric CancerPhase 2NCT00006389

Bryostatin 1 and Cisplatin in Treating Patients With Metastatic or Unresectable Stomach Cancer

A Phase 2 study testing bryostatin 1, cisplatin and laboratory biomarker analysis in people with Stage III Gastric Cancer and Stage IV Gastric Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Stage III Gastric Cancer, Stage IV Gastric Cancer
What is being tested?: bryostatin 1, cisplatin and laboratory biomarker analysis
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: Oct 2000to Mar 2010
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Diagnosis of metastatic or unresectable carcinoma of the stomach
Measurable disease
No brain metastasis
Performance status - Karnofsky 70-100%
More than 3 months
WBC at least 3,000/mm^3

Show all 27Show fewer

Platelet count at least 100,000/mm^3
Hemoglobin at least 10 g/dL
No history of any bleeding disorders
Bilirubin no greater than 1.5 mg/dL
Transaminases no greater than 2 times normal
Creatinine no greater than 1.5 mg/dL
Creatinine clearance at least 60 mL/min
No history of peptic ulceration or gastrointestinal bleeding
No active infection
No seizure disorder
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
HIV negative
No other serious concurrent illness that would preclude study entry
No medical, social, or psychological factors that would preclude study entry
No prior chemotherapy
No prior radiotherapy
More than 4 weeks since prior major surgery
Prior incomplete resection allowed
No other prior antitumor treatment

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Southern California
Los Angeles, California, 90033-0804

Other trials in United States

About this study

Official title: A Phase II Combination Trial of Bryostatin-1 and Cisplatin in the Treatment of Metastatic Gastric Cancer

Phase II trial to study the effectiveness of bryostatin 1 and cisplatin in treating patients who have metastatic or unresectable stomach cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Bryostatin 1 may increase the effectiveness of cisplatin by making tumor cells more sensitive to the drug. Combining cisplatin with bryostatin 1 may kill more tumor cells.

Read the detailed description

OBJECTIVES:

Determine the response rate and survival in patients with metastatic or unresectable carcinoma of the stomach treated with bryostatin 1 and cisplatin.

II. Determine the toxic effects of this regimen in these patients. III. Determine the molecular determinants of response to this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive bryostatin 1 IV over 72 hours on days 1-3 followed by cisplatin IV over 1 hour on day 4. Treatment repeats every 3 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity.

Conditions: Stage III Gastric Cancer, Stage IV Gastric Cancer
Being tested: bryostatin 1, cisplatin, 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.

bryostatin 1Drug
Also called B705008K112, BRYO, Bryostatin
Given IV
cisplatinDrug
Also called CACP, CDDP, CPDD, DDP
Given IV
laboratory biomarker analysisOther
Correlative studies

Study groups in NCT00006389
Study group	Role	What they receive
Treatment	Experimental	Patients receive bryostatin 1 IV over 72 hours on days 1-3 followed by cisplatin IV over 1 hour on day 4. Treatment repeats every 3 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. Receives: Drug: bryostatin 1; Drug: cisplatin; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

Observed Response Rate.
All patients had measurable disease and were assessed after 2 cycles of chemotherapy by medical photograph, plain x-ray, CT, MRI or other imaging scans of at least 2.0 cm or greater with conventional techniques or 1.0 cm or greater with spiral CT. Patients were evaluated by RECIST criteria. All measurable lesions, up to 10 "target lesions" were recorded and measured at baseline across the longest diameter (LD). All other non-target lesions were documented as present or absent. Complete Response (CR) was defined as complete disappearance of the tumor, partial response (PR) was defined as at least a 30% decrease of the sum of the LD of the target lesions, using the baseline sum LD as the reference
The observed response rate was defined as the percentage of evaluable patients whose best response is a CR or PR with associated 95% confidence interval.
Measured: Best response recorded from the start of treatment until disease progression/recurrence. Assessed every 2 cycles.

Secondary outcomes (2)

Overall Survival
Overall survival was estimated according to the Kaplan-Meier product-limit method.
Measured: 18 months
Progression-free Survival
Progression-free survival was estimated according to the Kaplan-Meier product-limit method
Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2000Mar 2010

First posted27 Jan 2003 (estimated)
Study startOct 2000
Primary completionMar 2010
Study completionMar 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Stage III Gastric CancerStudies 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: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00006389
Sponsor's protocol ID: NCI-2012-02361
Other IDs: NCI-2012-02361, CHNMC-PHII-22, CDR0000068267, NCI-T99-0040, PHII-22 (USC 3S-00-1), T99-0040, N01CM17101
Status last verified: Oct 2013
First submitted: 4 Oct 2000
Last updated: 1 Oct 2014
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Stage III Gastric Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Combination Trial of Bryostatin-1 and Cisplatin in the Treatment of Metastatic Gastric Cancer
ClinicalTrials.gov ID: NCT00006389
Acronym / sponsor ID: NCI-2012-02361
Conditions: Stage III Gastric Cancer, Stage IV Gastric Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: National Cancer Institute (NCI)US National Institutes of Health
Study start: Oct 2000
Primary completion: Mar 2010 (actual)
Study completion: Mar 2010 (actual)
First posted: 27 Jan 2003 (estimated)
Results: Posted 1 Oct 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

OBJECTIVES:

Determine the response rate and survival in patients with metastatic or unresectable carcinoma of the stomach treated with bryostatin 1 and cisplatin.

II. Determine the toxic effects of this regimen in these patients. III. Determine the molecular determinants of response to this regimen in these patients.

OUTLINE: This is a multicenter study.

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: bryostatin 1, Drug: cisplatin, Other: laboratory biomarker analysisPatients receive bryostatin 1 IV over 72 hours on days 1-3 followed by cisplatin IV over 1 hour on day 4. Treatment repeats every 3 weeks for a minimum of 2 courses 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)

Diagnosis of metastatic or unresectable carcinoma of the stomach
Measurable disease
No brain metastasis
Performance status - Karnofsky 70-100%
More than 3 months

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
bryostatin 1Also: B705008K112, BRYO, BryostatinGiven IV	Drug	Treatment
cisplatinAlso: CACP, CDDP, CPDD, DDPGiven IV	Drug	Treatment
laboratory biomarker analysisCorrelative studies	Other	Treatment

Primary outcome

Observed Response Rate.
Time frame: Best response recorded from the start of treatment until disease progression/recurrence. Assessed every 2 cycles.
All patients had measurable disease and were assessed after 2 cycles of chemotherapy by medical photograph, plain x-ray, CT, MRI or other imaging scans of at least 2.0 cm or greater with conventional techniques or 1.0 cm or greater with spiral CT. Patients were evaluated by RECIST criteria. All measurable lesions, up to 10 "target lesions" were recorded and measured at baseline across the longest diameter (LD). All other non-target lesions were documented as present or absent. Complete Response (CR) was defined as complete disappearance of the tumor, partial response (PR) was defined as at least a 30% decrease of the sum of the LD of the target lesions, using the baseline sum LD as the reference The observed response rate was defined as the percentage of evaluable patients whose best response is a CR or PR with associated 95% confidence interval.

2 secondary outcomes

Overall Survival
Time frame: 18 months
Progression-free Survival
Time frame: 18 months

Results and safety

Results posted to the registry on 1 Oct 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment	12	11

Primary outcome: Observed Response Rate.

Time frame: Best response recorded from the start of treatment until disease progression/recurrence. Assessed every 2 cycles.. Number (95% Confidence Interval). Unit: Percentage of Participants

Measure	Treatment n = 12
Value	0 (0 to 26.5)

Population analysed: The first 15 patients accrued to an Optimal Three-Stage Phase II design. If 3 or more responses are seen then 18 additional evaluable patients will be accrued to the second stage.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year, 5 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment	5 of 12 (41.7%)	12 of 12 (100%)	Not reported

Limitations and caveats (from the sponsor): Of 12 pts accrued\\treated, none responded. The initial phase accrual goal was 15, but given the 12 non-responders, we determined the probability of 3 future pts all responding (stochastic curtailed sampling) at 2.7%. Decided to terminate the trial.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Heinz-Josef Lenz principal investigator

University of Southern California

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 1 Oct 2014. 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?

Yes. Results are posted in the registry (first posted 1 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Observed Response Rate. (time frame: Best response recorded from the start of treatment until disease progression/recurrence. Assessed every 2 cycles.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00006389.

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 1 Oct 2014.