Clinical trial · Interventional
DX-8951f in Treating Patients With Metastatic Stomach Cancer
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
NCT00017212CI-TRIAL-00006917completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| exatecan mesylate | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 studyReferences
Publications (1)
- RESULTAjani 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 Drugs. 2005 Oct;23(5):479-84. doi: 10.1007/s10637-005-2907-z. PMID 16133799