Ignite Creation Date:
2025-12-24 @ 2:10 PM
Ignite Modification Date:
2026-02-22 @ 3:56 PM
Study NCT ID:
NCT00004095
Status:
COMPLETED
Last Update Posted:
2017-04-18
First Post:
1999-12-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Irinotecan Plus Gemcitabine in Treating Patients With Unresectable or Metastatic Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}, {'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}, {'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D000077146', 'term': 'Irinotecan'}], 'ancestors': [{'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-14', 'studyFirstSubmitDate': '1999-12-10', 'studyFirstSubmitQcDate': '2003-05-06', 'lastUpdatePostDateStruct': {'date': '2017-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2003-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['stage IV colon cancer', 'stage IV breast cancer', 'recurrent breast cancer', 'recurrent non-small cell lung cancer', 'recurrent pancreatic cancer', 'stage IV rectal cancer', 'recurrent colon cancer', 'recurrent rectal cancer', 'stage IV renal cell cancer', 'recurrent renal cell cancer', 'extensive stage small cell lung cancer', 'recurrent small cell lung cancer', 'recurrent bladder cancer', 'stage IV bladder cancer', 'stage IV non-small cell lung cancer', 'stage IV pancreatic cancer'], 'conditions': ['Bladder Cancer', 'Breast Cancer', 'Colorectal Cancer', 'Kidney Cancer', 'Lung Cancer', 'Pancreatic Cancer']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Wisinski KB, Mulcahy MF, Newman S, et al.: A phase I study of irinotecan and gemcitabine in solid tumors. [Abstract] American Society of Clinical Oncology 2007 Gastrointestinal Cancers Symposium, 19 -21 January 2007, Orlando, Florida A-140, 2007.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.\n\nPURPOSE: Phase I trial to study the effectiveness of combining irinotecan and gemcitabine in treating patients who have unresectable or metastatic solid tumors.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the maximum tolerated dose (MTD) and the principal toxicities of irinotecan and gemcitabine in patients with surgically unresectable or metastatic solid tumors.\n* Determine if the principal toxicities and MTD of this combination regimen are affected by drug sequencing in this patient population.\n* Determine the potential for gemcitabine to alter the pharmacokinetic characteristics when administered with irinotecan in these patients.\n* Describe the influence effected by varying the administration sequence of this combination regimen in this patient population.\n* Obtain preliminary data regarding efficacy of this combination regimen in these patients.\n\nOUTLINE: This is a dose-escalation study.\n\nPatients receive irinotecan IV over 90 minutes followed by gemcitabine IV over 30 minutes on days 1 and 15. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Once the maximum tolerated dose (MTD) is reached, patients receive subsequent doses of the inverse sequence of the combination drugs until a new MTD is determined.\n\nCohorts of 3-6 patients receive escalating doses of irinotecan and gemcitabine until the MTD is reached. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicities.\n\nPatients are followed every 3 months until death.\n\nPROJECTED ACCRUAL: At least 12 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed metastatic or surgically unresectable solid tumor, having received the following maximum number of prior therapies for advanced disease:\n\n * Bladder cancer - no more than 1 prior therapy\n * Breast cancer - no more than 2 prior therapies\n * Colorectal cancer - no more than 1 prior therapy\n * Kidney cancer - no prior therapy\n * Lung cancer - no more than 1 prior therapy\n * Pancreatic cancer - no prior therapy\n* Bidimensionally measurable disease outside a previously irradiated field\n\n * At least 2 cm x 2 cm\n* No known bone metastases\n* CNS involvement allowed if successfully controlled by surgery or radiotherapy and not requiring corticosteroids\n* Hormone receptor status:\n\n * Not specified\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nMenopausal status:\n\n* Not specified\n\nPerformance status:\n\n* ECOG 0-2\n\nLife expectancy:\n\n* At least 3 months\n\nHematopoietic:\n\n* Granulocyte count at least 1,500/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n\nHepatic:\n\n* Bilirubin no greater than 1.5 mg/dL regardless of liver involvement secondary to tumor\n* SGOT no greater than 3 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present)\n* No known Gilbert's disease\n\nRenal:\n\n* Creatinine no greater than 1.8 mg/dL\n* Calcium less than 12.0 mg/dL\n\nCardiovascular:\n\n* No myocardial infarction within the past 6 months\n* No congestive heart failure requiring therapy\n\nOther:\n\n* No active uncontrolled bacterial, viral (including HIV), or invasive fungal infection\n* No psychiatric disorders that would prevent compliance\n* No other malignancy within the past 5 years except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix\n* No history of seizures\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* No concurrent sargramostim (GM-CSF)\n* No concurrent immunotherapy\n\nChemotherapy:\n\n* No prior irinotecan, topotecan, or gemcitabine\n* Prior adjuvant chemotherapy allowed, if at least 1 year between last dose of adjuvant chemotherapy and recurrence of cancer\n* No other concurrent chemotherapy\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* See Disease Characteristics\n* At least 4 weeks since prior radiotherapy to less than 30% of bone marrow\n* No prior whole pelvic radiotherapy\n* No concurrent radiotherapy\n\nSurgery:\n\n* See Disease Characteristics\n\nOther:\n\n* No concurrent phenytoin, phenobarbital, or other antiepileptic prophylaxis"}, 'identificationModule': {'nctId': 'NCT00004095', 'briefTitle': 'Irinotecan Plus Gemcitabine in Treating Patients With Unresectable or Metastatic Solid Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Phase I Trial of Irinotecan (CPT-11) and Gemcitabine in Patients With Solid Tumors', 'orgStudyIdInfo': {'id': 'NU 98X3'}, 'secondaryIdInfos': [{'id': 'NU-98X3'}, {'id': 'P-UPJOHN-976475157'}, {'id': 'NCI-G99-1588'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Irinotecan Plus Gemcitabine', 'interventionNames': ['Drug: gemcitabine hydrochloride', 'Drug: irinotecan hydrochloride']}], 'interventions': [{'name': 'gemcitabine hydrochloride', 'type': 'DRUG', 'armGroupLabels': ['Irinotecan Plus Gemcitabine']}, {'name': 'irinotecan hydrochloride', 'type': 'DRUG', 'armGroupLabels': ['Irinotecan Plus Gemcitabine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Robert H. Lurie Comprehensive Cancer Center at Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Al B. Benson, MD, FACP', 'role': 'STUDY_CHAIR', 'affiliation': 'Robert H. Lurie Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}