Gemcitabine and Irinotecan in Treating Patients With Locally Advanced Unresectable or Metastatic Kidney Cancer

NCT00089102 | Terminated Phase 2 Results DMC

• 5 other identifiers: CDR0000378044MUSC-100730MUSC-HR-10981PHARMACIA-B9E-US-X388LILLY-MUSC-100730
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and irinotecan, work in 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: This phase II trial is studying how well giving gemcitabine together with irinotecan works in treating patients with locally advanced unresectable or metastatic kidney cancer.

Conditions

Kidney Cancer

Keywords

recurrent renal cell cancer; stage III renal cell cancer; stage IV renal cell cancer

Outcome Measures

Primary Outcomes (1)

• Response Proportion

  From registration until time of complete response or partial response

Secondary Outcomes (3)

• Duration of Response

  From registration until disease progression among patients who had at least a partial response

• Number of Participants Who Experienced SAEs on Study

  From the day of first dose until the end of study, for an average of 6 months

• Progression-free Survival

  Time between registration and disease progression or death, whichever comes first.

Study Arms (1)

Gemcitabine + Irinotecan

EXPERIMENTAL

Drug: gemcitabine hydrochloride; Drug: irinotecan hydrochloride

Interventions

gemcitabine hydrochloride DRUG

1,000 mg/m2/dose in 250 cc of NS IV over 30 minutes on Days 1 and 8 of each 21 day cycle

Gemcitabine + Irinotecan

irinotecan hydrochloride DRUG

100mg/m2/dose in 500 cc of D5W or NS IV over 90 minutes on days 1 and 8 of each 21 day cycle

Gemcitabine + Irinotecan

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed renal cell carcinoma * Locally advanced unresectable or metastatic disease * Unidimensionally measurable disease by physical exam or imaging study * The following are not considered measurable disease: * Bone only disease * Pleural or peritoneal effusions * CNS lesions * Irradiated lesions unless disease progression was documented after radiotherapy PATIENT CHARACTERISTICS: Age * Over 18 Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * Granulocyte count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * ALT and AST \< 3 times upper limit of normal * Bilirubin ≤ 2.0 mg/dL Renal * Creatinine ≤ 2.0 mg/dL Gastrointestinal * No active inflammatory bowel disease * No significant bowel obstruction * No chronic diarrhea Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after study participation * No mental incapacitation or psychiatric illness that would preclude giving informed consent * No other active malignancy except nonmelanoma skin cancer * No other severe disease that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * At least 4 weeks since prior immunotherapy * No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF) Chemotherapy * No prior chemotherapy * No other concurrent chemotherapy Endocrine therapy * No concurrent hormones except steroids for adrenal failure, hormones for non-disease-related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic Radiotherapy * See Disease Characteristics * At least 4 weeks since prior radiotherapy * No concurrent palliative radiotherapy Surgery * Not specified Other * No concurrent participation in another clinical trial

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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (2)

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

Location

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

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; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; 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

Results Point of Contact

• Title: Kate Anderton
• Organization: Medical University of South Carolina

anderton@musc.edu

843-792-2708

Study Officials

• Uzair B. Chaudhary, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

• Gustavo Leone

  Medical University of South Carolina, Hollings Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2004
• First Posted: August 5, 2004
• Study Start: September 1, 2003
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: July 16, 2018
• Results First Posted: July 16, 2018

Record last verified: 2018-07

Locations

US (2)