T900607 in Treating Patients With Gastroesophageal Junction Cancer

NCT00054249 | Completed Phase 2

• 4 other identifiers: TULA-T-607-006CWRU-060214MCDR0000269917TULA-TULI-1202
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastric Cancer

Keywords

recurrent gastric cancer

Interventions

T900607 DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University Hospitals Seidman Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Ireland Cancer Center

Cleveland, Ohio, 44106-1714, United States

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

T 900607

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Joanna M. Brell, MD

  Case Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 5, 2003
• First Posted: February 6, 2003
• Study Start: September 1, 2002
• Primary Completion: October 1, 2004
• Study Completion: September 1, 2010
• Last Updated: July 18, 2013

Record last verified: 2010-09

Locations

US (1)