Irinotecan Plus Gemcitabine in Treating Patients With Unresectable or Metastatic Solid Tumors

NCT00004095 | Completed Phase 1

• 4 other identifiers: NU 98X3NU-98X3P-UPJOHN-976475157NCI-G99-1588
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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. PURPOSE: Phase I trial to study the effectiveness of combining irinotecan and gemcitabine in treating patients who have unresectable or metastatic solid tumors.

Conditions

Bladder Cancer; Breast Cancer; Colorectal Cancer; Kidney Cancer; Lung Cancer; Pancreatic Cancer

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

Study Arms (1)

Irinotecan Plus Gemcitabine

EXPERIMENTAL

Drug: gemcitabine hydrochloride; Drug: irinotecan hydrochloride

Interventions

gemcitabine hydrochloride DRUG

Irinotecan Plus Gemcitabine

irinotecan hydrochloride DRUG

Irinotecan Plus Gemcitabine

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed metastatic or surgically unresectable solid tumor, having received the following maximum number of prior therapies for advanced disease: * Bladder cancer - no more than 1 prior therapy * Breast cancer - no more than 2 prior therapies * Colorectal cancer - no more than 1 prior therapy * Kidney cancer - no prior therapy * Lung cancer - no more than 1 prior therapy * Pancreatic cancer - no prior therapy * Bidimensionally measurable disease outside a previously irradiated field * At least 2 cm x 2 cm * No known bone metastases * CNS involvement allowed if successfully controlled by surgery or radiotherapy and not requiring corticosteroids * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 18 and over Menopausal status: * Not specified Performance status: * ECOG 0-2 Life expectancy: * At least 3 months Hematopoietic: * Granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 mg/dL regardless of liver involvement secondary to tumor * SGOT no greater than 3 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present) * No known Gilbert's disease Renal: * Creatinine no greater than 1.8 mg/dL * Calcium less than 12.0 mg/dL Cardiovascular: * No myocardial infarction within the past 6 months * No congestive heart failure requiring therapy Other: * No active uncontrolled bacterial, viral (including HIV), or invasive fungal infection * No psychiatric disorders that would prevent compliance * No other malignancy within the past 5 years except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix * No history of seizures * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent sargramostim (GM-CSF) * No concurrent immunotherapy Chemotherapy: * No prior irinotecan, topotecan, or gemcitabine * Prior adjuvant chemotherapy allowed, if at least 1 year between last dose of adjuvant chemotherapy and recurrence of cancer * No other concurrent chemotherapy Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics * At least 4 weeks since prior radiotherapy to less than 30% of bone marrow * No prior whole pelvic radiotherapy * No concurrent radiotherapy Surgery: * See Disease Characteristics Other: * No concurrent phenytoin, phenobarbital, or other antiepileptic prophylaxis

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

Sponsors & Collaborators

• Northwestern University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• 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.

  RESULT

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Breast Neoplasms; Colorectal Neoplasms; Kidney Neoplasms; Lung Neoplasms; Pancreatic Neoplasms; Colonic Neoplasms; Carcinoma, Non-Small-Cell Lung; Rectal Neoplasms; Carcinoma, Renal Cell; Small Cell Lung Carcinoma

Interventions

Gemcitabine; Irinotecan

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Kidney Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Camptothecin; Alkaloids

Study Officials

• Al B. Benson, MD, FACP

  Robert H. Lurie Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 1999
• First Posted: May 7, 2003
• Study Start: August 1, 1999
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: April 18, 2017

Record last verified: 2017-04

Locations

US (1)