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Gastric CancerPhase 1/2NCT00209612

Phase I/II Study of Paclitaxel Plus CPT-11 in Pts. With 2nd Line Chemotherapy of Inoperable or Recurrent GC.

A Phase 1/2 study testing Taxol and Campt, Topotesin in people with Gastric Cancer, run by Hokkaido Gastrointestinal Cancer Study Group at 1 site in Japan.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

A phase I/II study is conducted to determine the maximum-tolerated dose (MTD), dose-limiting toxicity (DLT), and efficacy of a combination chemotherapy using CPT-11 and Paclitaxel in pre-treated patients with metastatic gastric cancer. Read more about this study

Who is it for?
Ages Up to 75 years
Conditions the study is for
Gastric Cancer
What is being tested?
Taxol and Campt, Topotesin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteJapan
Study dates
Apr 2004to Mar 2009
Phase
Phase 1/2
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 Up to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Histologically confirmed metastatic or recurrent gastric cancer with prior treatment for advanced disease.
  • Patients who have received 1cycle cancer therapy (radiotherapy, chemotherapy or chemoradiotherapy) given > 4 weeks prior to the beginning of study therapy
  • At least one measurable lesion according to the RECIST criteria. Minimum indicator lesion size: > 10 mm measured by spiral CT or >20mm measured by conventional techniques(Except for Phase I setting).
  • Patients aged between 20 and 75 years, inclusive, at the time of acquisition of informed consent
  • Patients with performance status(ECOG) 0 to 2
  • Abnormal hematologic values (WBC ≥ 3.5 x 109/L, Hemoglobin ≥ 9.0g/dl, platelet count ≥ 100 x 109/L)
Show all 11Show fewer
  • Serum cleatinine ≤ 1.5mg/dl
  • Serum bilirubin ≤ 1.5mg/dl. ALT, AST ≤ 2.0 x upper normal limit (or ≤ 3 x upper normal limit in the case of liver metastases)
  • Normal ECG
  • Life expectancy ≥ 3 months
  • Patients who have given written informed consent to participate in this study

Who cannot join

  • Patients with active multiple cancers; or even if the multiple cancers are metachronous, have a disease-free period of less than 5 years (but excluding cancer in situ and skin cancer) (Except for Phase I setting)
  • Serious, uncontrolled, concurrent infection(s) or illness(es)
  • Patients with no serious concurrent complications (such as heart disease, Intestinal pneumonia)
  • Patients with Liver cirrhosis
  • Patients with fresh hemorrhage from the gastrointestinal tract
  • Patients with poorly controlled diabetes or are treated by continuous use of insulin
Show all 17Show fewer
  • Patients with concurrent psychiatric disease or psychotic symptoms, and judged to have difficulties participating in the study
  • Patients with retention of body fluid(pleural effusion, ascites, pericardial effusion) necessitating treatment
  • Patients with diarrhea (watery stool)
  • Patients with infection, intestinal palsy or intestinal occlusion
  • Patients with brain metastasis
  • Patients with Gilbert syndrome
  • Patients who have experienced serious drug allergy in the past
  • Patients who are pregnant and lactating or hope to become pregnant during the study period
  • Patients with prior Taxan (Paclitaxel, Docetaxel) or CPT-11 treatment
  • Patients with neuropathy ≥ grade 2
  • Others, patients judged by the investigator or subinvestigator to be inappropriate as subject

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • ・ Hokkaido University Hospital (Hokkaido University Graduate School of Medicine / School of Medicine)

    Sapporo, Hokkaido, 060-8638

Other trials in Japan

About this study

Official title: Phase I/II Study of Biweekly Administration Regimen of Paclitaxel Combined With CPT-11 in Patients With Second Line Chemotherapy of Inoperable or Recurrent Gastric Cancer(GC).

A phase I/II study is conducted to determine the maximum-tolerated dose (MTD), dose-limiting toxicity (DLT), and efficacy of a combination chemotherapy using CPT-11 and Paclitaxel in pre-treated patients with metastatic gastric cancer. The usefulness of the this regimen is evaluated by response rate, median survival time, and progression free survival.

Read the detailed description

Patients with pre-treated measurable metastatic gastric cancer were included in this trial. Patients received this combination chemotherapy repeated every 28 days until progression disease. Starting dose (dose level 1) were CPT-11 80 mg/m2 on day 1 and 15, Paclitaxel 60 mg/m2 on day 1 and 15. DLT was defined as follows (according to NCI-CTC version 2.0); Grade 4 neutropenia, thrombocytopenia(≥25000), Grade 3 neutropenia accompanied fever (>38℃) , and Grade 3 non-hematological toxicity (except for nausea, vomit, appetite loss , general fatigue, alopecia). Maximal Tolerated Dose (MTD) is determined when the incidence of critical toxicity exceeds 50% at a certain dose level. Response rate will be calculated according to RECIST criteria.

Conditions
Gastric Cancer
Being tested
Taxol, Campt, Topotesin
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TaxolDrug

    Also called Paclitaxel

    Day1,15 X mg/m2, IV (in the vein)

  • Campt, TopotesinDrug

    Also called irinotecan

    Day1,15 Y mg/m2, IV (in the vein)

Study groups in NCT00209612
Study groupRoleWhat they receive
1ExperimentalPaclitaxel+Irinotecan
Receives: Drug: Taxol; Drug: Campt, Topotesin

What is being measured

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

  1. Determine the DLT(Dose Limiting Toxicity) and MTD(Maximum Tolerated Dose) in Phase I setting. Determine the clinical response rate with Recommended dose in Phase II setting.

    Measured: 1-year

Secondary outcomes (2)

  1. Determine the clinical response rate of patients in Phase I setting.

    Measured: 1-year

  2. Determine the MST(Median Survival Time) and PFS(Progression Free Survival) in Phase II setting.

    Measured: 2-years

Timeline

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

  1. First posted21 Sep 2005 (estimated)
  2. Study startApr 2004
  3. Primary completionNov 2008 (estimated)
  4. Study completionMar 2009 (estimated)

Why it stopped: due to strong side effect

Resources

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00209612
Sponsor's protocol ID
HGCSG0402
Other IDs
PacIri
Status last verified
Feb 2009
First submitted
13 Sep 2005
Last updated
17 Feb 2009
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Taxol and Campt, Topotesin in people with Gastric Cancer, run by Hokkaido Gastrointestinal Cancer Study Group at 1 site in Japan.

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 11 inclusion and 17 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: withdrawn, as of the sponsor's last update on 17 Feb 2009. 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 Japan. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 was withdrawn before enrolling participants, so there are no results.

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?

Determine the DLT(Dose Limiting Toxicity) and MTD(Maximum Tolerated Dose) in Phase I setting. Determine the clinical response rate with Recommended dose in Phase II setting. (time frame: 1-year). 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 NCT00209612.

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 Feb 2009.

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