Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:33 AM
Study NCT ID:
NCT00080002
Status:
TERMINATED
Last Update Posted:
2012-09-06
First Post:
2004-03-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Pegamotecan (PEG-Camptothecin) in Localized or Metastatic Cancer of the Stomach or Gastroesophageal Junction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C115093', 'term': 'pegamotecan'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2003-12'}, 'statusVerifiedDate': '2005-03', 'lastUpdateSubmitDate': '2012-09-05', 'studyFirstSubmitDate': '2004-03-19', 'studyFirstSubmitQcDate': '2004-03-22', 'lastUpdatePostDateStruct': {'date': '2012-09-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-03-23', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['cancer', 'gastric', 'gastroesophageal junction', 'neoplasms', 'gastric cancer', 'gastric neoplasms'], 'conditions': ['Cancer of Stomach', 'Gastroesophageal Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of pegamotecan (PEG-camptothecin) in patients with pathologically-diagnosed locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction who have relapsed or progressed following one prior chemotherapy treatment regimen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathologically confirmed diagnosis of adenocarcinoma of the stomach or gastroesophageal junction.\n* Disease measurable in at least one dimension.\n* Target tumors outside of prior radiation field(s).\n* An Eastern Cooperative Oncology Group (ECOG) performance scale score of 0 or 1\n* Adequate hematologic profile, as determined by hemoglobin, platelet, and neutrophil count.\n* Adequate renal function, as determined by serum creatinine and serum albumin measurements.\n* Adequate liver function, as determined by total bilirubin and transaminases levels. Transaminases may be \\<= 5.0x ULN if due to metastatic disease in the liver.\n* Fully recovered from prior surgery.\n* No history of hemorrhagic cystitis.\n* No microscopic hematuria (\\>10 RBC/hpf) unless documented to be due to an infection or non-bladder origin.\n* Capable of understanding the protocol requirements and risks and providing written informed consent.\n\nExclusion Criteria:\n\n* Concurrent serious medical illness unrelated to tumor within the past 6 months.\n* Known chronic infectious disease, such as AIDS or hepatitis (screening for hepatitis and HIV will not be performed).\n* Positive screening pregnancy test or is breast-feeding.\n* Female or male subject of reproductive capacity who is unwilling to use methods appropriate to prevent pregnancy during the course of this study.\n* Receiving concurrent chemotherapy, investigational agents, radiotherapy, surgery, or has received wide field radiation within the previous 4 weeks.\n* History of another malignancy (except basal and squamous cell carcinomas of the skin and carcinoma in situ of the cervix) within the last 5 years.\n* Known or clinically suspected brain metastases.\n* Received more than one prior regimen of chemotherapy for locally advanced or metastatic adenocarcinoma of the stomach or GE junction.\n* Received prior neoadjuvant and/or adjuvant cytotoxic chemotherapy\n* Received any investigational drug within the last 30 days.\n* Not fully recovered from any prior, and from any reversible side effects related to the administration of cytotoxic chemotherapy, investigational agents, or radiation therapy.\n* Prior treatment with a camptothecin analog.'}, 'identificationModule': {'nctId': 'NCT00080002', 'briefTitle': 'Efficacy of Pegamotecan (PEG-Camptothecin) in Localized or Metastatic Cancer of the Stomach or Gastroesophageal Junction', 'organization': {'class': 'INDUSTRY', 'fullName': 'Enzon Pharmaceuticals, Inc.'}, 'officialTitle': 'Effectiveness and Safety Study of Pegamotecan (PEG-Camptothecin) in Patients With Locally Advanced or Metastatic Cancer of the Stomach or Gastroesophageal Junction Who Have Relapsed or Progressed Following a Previous Chemotherapy Treatment', 'orgStudyIdInfo': {'id': 'CAM-9011'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Pegamotecan', 'type': 'DRUG'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Enzon Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}}}}