T900607 in Treating Patients With Gastroesophageal Junction Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Study Completion Date

2010-09-30

Brief Summary

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RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of T900607 in treating patients who have gastroesophageal junction cancer.

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Detailed Description

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OBJECTIVES:

* Determine the response rate (complete and partial) in patients with previously treated gastric or gastroesophageal junction carcinoma treated with T900607. (Gastric carcinoma closed to accrual as of 02/04.)
* Determine the duration of response and time to disease progression in patients treated with this drug.
* Determine the pharmacokinetics of this drug in these patients.
* Determine the safety profile of this drug in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive T900607 IV over 1 hour once weekly. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 20-35 patients will be accrued for this study.

Conditions

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Gastric Cancer

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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T900607

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed gastric or gastroesophageal junction carcinoma (gastric carcinoma closed to accrual as of 02/04)
* Must have received 1 or 2 prior chemotherapy regimens for gastric carcinoma (gastric carcinoma closed to accrual as of 02/04)
* Bidimensionally measurable disease

* At least 1 lesion that is at least 10 mm by CT scan
* No CNS metastases or carcinomatous meningitis

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* Karnofsky 70-100%

Life expectancy

* At least 12 weeks

Hematopoietic

* Absolute neutrophil count ≥ 1,500/mm\^3\*
* Platelet count ≥ 100,000/mm\^3\*
* Hemoglobin ≥ 8.5 g/dL\* NOTE: \*Independent of growth factor or transfusion support

Hepatic

* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* AST and ALT ≤ 3 times ULN
* INR ≤ 1.5 (unless receiving anticoagulants)
* Albumin \> 2.5 g/dL

Renal

* Creatinine ≤ 2 times ULN

Cardiovascular

* No New York Heart Association class III or IV heart disease
* LVEF ≥ 50%
* No acute anginal symptoms

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after study participation
* Able to comply with study procedures and follow-up
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
* No severe infection
* No other concurrent severe medical condition or comorbidity that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

* More than 7 days since prior growth factors or blood transfusions
* No concurrent therapeutic biological response modifier therapy
* No concurrent immunotherapy

Chemotherapy

* See Disease Characteristics
* No other concurrent cytotoxic chemotherapy

Endocrine therapy

* No concurrent hormonal therapy

Radiotherapy

* No concurrent radiotherapy (including palliative radiotherapy)

Surgery

* More than 4 weeks since prior major surgery

Other

* More than 4 weeks since prior investigational agents
* No other concurrent investigational anticancer therapy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No