Gastric Cancer Clinical Trial
Official title:
A Phase II Study Of Intravenous Exatecan Mesylate (DX-891F) Administered Daily For Five Days Every Three Weeks To Patients With Previously Untreated Metastatic Gastric Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of exatecan mesylate in treating patients
who have metastatic stomach cancer.
Status | Completed |
Enrollment | 0 |
Est. completion date | September 2003 |
Est. primary completion date | September 2003 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically confirmed gastric or gastroesophageal adenocarcinoma - Lymph node involvement and/or distant metastasis - No squamous cell carcinoma, small cell carcinoma, lymphoma, or leiomyosarcoma of the stomach - Measurable disease with indicator lesions outside the field of prior radiotherapy - At least 20 mm by conventional scan OR - At least 10 mm by spiral CT scan - Nonmeasurable lesions include the following: - Primary tumor - Bone lesions - Leptomeningeal disease - Ascites - Pleural/pericardial effusion - Inflammatory breast disease - Lymphangitis cutis/pulmonitis - Cystic lesions - Abdominal masses not confirmed and followed by imaging techniques - No prior treatment for locally advanced or metastatic disease - Prior adjuvant treatment allowed if disease recurrence noted at least 6 months after completion of adjuvant treatment - No known brain metastases PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - At least 12 weeks Hematopoietic: - Absolute neutrophil count at least 1,500/mm3 - Platelet count at least 100,000/mm3 - Hemoglobin at least 9.0 g/dL Hepatic: - Bilirubin no greater than 2.0 mg/dL - AST or ALT no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases present) - Albumin at least 2.8 g/dL - PT or INR no greater than 1.5 times ULN (coumadin independent) Renal: - Creatinine no greater than 1.5 mg/dL Cardiovascular: - No active congestive heart failure - No uncontrolled angina - No myocardial infarction within the past 6 months Other: - No concurrent serious infection - No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix - No overt psychosis, mental disability, or incompetence that would preclude informed consent - No other life-threatening illness - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: - See Disease Characteristics Biologic therapy: - No concurrent anti-cancer biologic therapy - No concurrent prophylactic colony stimulating factors during first course of therapy Chemotherapy: - Recovered from prior adjuvant chemotherapy - No other concurrent anti-cancer chemotherapy - No other concurrent anti-cancer cytotoxic therapy Endocrine therapy: - Concurrent megestrol for appetite stimulation allowed Radiotherapy: - At least 4 weeks since prior radiotherapy and recovered - No prior wide-field radiotherapy to more than 25% of bone marrow - No concurrent anti-cancer radiotherapy Surgery: - At least 4 weeks since prior major surgery and recovered - No concurrent anti-cancer surgery Other: - No other investigational drugs (including analgesics or antiemetics) for at least 4 weeks prior to, during, and for 4 weeks after study |
Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Cancer Care Ontario-Hamilton Regional Cancer Centre | Hamilton | Ontario |
United States | Simmons Cancer Center - Dallas | Dallas | Texas |
United States | Rocky Mountain Cancer Centers | Denver | Colorado |
United States | University of Texas - MD Anderson Cancer Center | Houston | Texas |
United States | Pacific Shores Medical Group | Long Beach | California |
United States | Cancer Therapy and Research Center | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
Daiichi Sankyo Inc. |
United States, Canada,
Ajani JA, Takimoto C, Becerra CR, Silva A, Baez L, Cohn A, Major P, Kamida M, Feit K, De Jager R. A phase II clinical and pharmacokinetic study of intravenous exatecan mesylate (DX-8951f) in patients with untreated metastatic gastric cancer. Invest New Dr — View Citation
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05551416 -
The EpiGASTRIC/EDGAR Project: New Strategies for the Early Detection and Prevention of Gastric Cancer
|
||
Completed |
NCT05518929 -
Hypoxia During Gastroenterological Endoscope Procedures Sedated With Ciprofol In Overweight Or Obesity Patients
|
Phase 4 | |
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT03219593 -
Apatinib as the First-Line Therapy in Elderly Locally Advanced or Metastatic Gastric Cancer
|
Phase 2 | |
Recruiting |
NCT05489211 -
Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)
|
Phase 2 | |
Recruiting |
NCT05536102 -
The Effectiveness and Safety of XELOX and Tislelizumab + PLD for Resectable Gastric Cancer (LidingStudy)
|
Phase 2 | |
Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT06010862 -
Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors
|
Phase 1 | |
Recruiting |
NCT05415098 -
Study of Safety, Pharmacokinetic and Efficacy of APG-5918 in Advanced Solid Tumors or Lymphomas
|
Phase 1 | |
Active, not recruiting |
NCT04082364 -
Combination Margetuximab, Retifanlimab, Tebotelimab, and Chemotherapy Phase 2/3 Trial in HER2+ Gastric/GEJ Cancer
|
Phase 2/Phase 3 | |
Withdrawn |
NCT03766607 -
Trastuzumab Beyond Progression in HER2 Positive Metastatic Gastric Cancer
|
Phase 2 | |
Recruiting |
NCT04118114 -
Phase II Study of PRL3-ZUMAB in Advanced Solid Tumors
|
Phase 2 | |
Completed |
NCT01924533 -
Efficacy and Safety Study of Olaparib in Combination With Paclitaxel to Treat Advanced Gastric Cancer.
|
Phase 3 | |
Terminated |
NCT01641939 -
A Study of Trastuzumab Emtansine Versus Taxane in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced Gastric Cancer
|
Phase 2/Phase 3 | |
Recruiting |
NCT05107674 -
A Study of NX-1607 in Adults With Advanced Malignancies
|
Phase 1 | |
Active, not recruiting |
NCT04908813 -
Study of HLX22 in Combanition With Trastuzumab and Chemotherapy Versus Placebo in Combination With Trastuzumab and Chemotherapy for Treatment of Locally Advanced or Metastatic Gastric Cancer
|
Phase 2 | |
Active, not recruiting |
NCT04249739 -
Pembrolizumab + Capecitabine/Oxaliplatin (CapeOx) -HER2 Nagative and Pembrolizumab + Trastuzumab + Cisplatin/Capecitabine HER2 Positive
|
Phase 2 | |
Recruiting |
NCT05514158 -
To Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Disitamab Vedotin Combined With RC98 in the Treatment of Subjects With HER2-expressing Locally Advanced or Metastatic Gastric Cancer (Including AEG)
|
Phase 1 | |
Recruiting |
NCT04931654 -
A Study to Assess the Safety and Efficacy of AZD7789 in Participants With Advanced or Metastatic Solid Cancer
|
Phase 1/Phase 2 | |
Recruiting |
NCT03175224 -
APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors
|
Phase 2 |