Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00089102
Other study ID # CDR0000378044
Secondary ID MUSC-100730MUSC-
Status Terminated
Phase Phase 2
First received
Last updated
Start date September 2003
Est. completion date July 2009

Study information

Verified date July 2018
Source Medical University of South Carolina
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

OBJECTIVES:

Primary

- Determine response in patients with locally advanced unresectable or metastatic renal cell carcinoma treated with gemcitabine and irinotecan.

Secondary

- Determine the duration of response in patients treated with this regimen.

- Determine the tolerance to and toxicity of this regimen in these patients.

- Determine median and progression-free survival in patients treated with this regimen.

OUTLINE: Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1 and 8. Treatment repeats every 21 days for 6-8 courses in the absence of disease progression or unacceptable toxicity. Patients receive 2 additional courses beyond best response.

Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 12-36 patients will be accrued for this study within 30 months.


Recruitment information / eligibility

Status Terminated
Enrollment 9
Est. completion date July 2009
Est. primary completion date July 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years to 120 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
gemcitabine hydrochloride
1,000 mg/m2/dose in 250 cc of NS IV over 30 minutes on Days 1 and 8 of each 21 day cycle
irinotecan hydrochloride
100mg/m2/dose in 500 cc of D5W or NS IV over 90 minutes on days 1 and 8 of each 21 day cycle

Locations

Country Name City State
United States Hollings Cancer Center at Medical University of South Carolina Charleston South Carolina
United States Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg South Carolina

Sponsors (1)

Lead Sponsor Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Response Proportion From registration until time of complete response or partial response
Secondary Duration of Response From registration until disease progression among patients who had at least a partial response
Secondary 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
Secondary Progression-free Survival Time between registration and disease progression or death, whichever comes first.
See also
  Status Clinical Trial Phase
Completed NCT00541008 - Sunitinib as First-Line Therapy in Treating Patients With Locally Advanced Metastatic Papillary Renal Cell Cancer Phase 2
Completed NCT03520231 - Study Comparing Denosumab With Standard Treatment in Urothelial Cancer Patients With Bone Metastases Phase 2
Recruiting NCT04623502 - An Investigation of Kidney and Urothelial Tumor Metabolism in Patients Undergoing Surgical Resection and/or Biopsy N/A
Terminated NCT00788125 - Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT04383210 - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors Phase 2
Active, not recruiting NCT03634540 - A Trial of Belzutifan (PT2977, MK-6482) in Combination With Cabozantinib in Patients With Clear Cell Renal Cell Carcinoma (ccRCC) (MK-6482-003) Phase 2
Completed NCT04534309 - Behavioral Weight Loss Program for Cancer Survivors in Maryland N/A
Active, not recruiting NCT01529658 - Renal Hypothermia During Partial Nephrectomy N/A
Completed NCT01048892 - Seneca Valley Virus-001 and Cyclophosphamide in Treating Young Patients With Relapsed or Refractory Neuroblastoma, Rhabdomyosarcoma, or Rare Tumors With Neuroendocrine Features Phase 1
Completed NCT00790569 - Varenicline or Nicotine Patch and Nicotine Gum in Helping Smokers in a Methadone Treatment Program Stop Smoking N/A
Withdrawn NCT00769990 - Genistein in Treating Patients Undergoing External-Beam Radiation Therapy for Bone Metastases Phase 1/Phase 2
Terminated NCT00896467 - Psychological and Emotional Impact in Patients Undergoing Treatment For Metastatic Cancer Either in a Clinical Trial or as Standard Off-Trial Therapy N/A
Recruiting NCT00301990 - Bevacizumab and Interleukin-2 in Treating Patients With Metastatic Kidney Cancer Phase 2
Completed NCT00467077 - Gefitinib and PEG-Interferon Alfa-2b in Treating Patients With Unresectable or Metastatic Kidney Cancer Phase 2
Completed NCT00098943 - NGR-TNF in Treating Patients With Advanced Solid Tumors Phase 1
Terminated NCT00899860 - Gene Expression in Normal Tissue and Tumor Tissue From Patients Who Have Undergone Surgery For Kidney Cancer N/A
Completed NCT00021021 - RPI.4610 in Treating Patients With Metastatic Kidney Cancer Phase 2
Completed NCT00006968 - Pentostatin Followed by Peripheral Stem Cell Transplantation in Treating Patients With Advanced Kidney Cancer Phase 1/Phase 2
Completed NCT00006022 - Interleukin-2 Plus Bryostatin 1 in Treating Patients With Melanoma or Kidney Cancer Phase 1
Withdrawn NCT00006126 - Peripheral Stem Cell Transplantation in Treating Patients With Melanoma or Small Cell Lung, Breast, Testicular, or Kidney Cancer That is Metastatic or That Cannot Be Treated With Surgery Phase 1