Pemetrexed Plus Gemcitabine in Renal Cell Cancer

NCT00491075 | Terminated Phase 2 Results

• 1 other identifier: 2005-0516
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective:

• To determine the clinical activity of Pemetrexed + Gemcitabine in non-clear cell renal cell cancer (RCC). Clinical activity will take into account response rate and progression free survival (PFS). Secondary Objectives:
• To determine the toxicity of Pemetrexed + Gemcitabine in non-clear cell RCC.
• To estimate the survival rate of patients with non-clear cell RCC treated with this combination.

Conditions

Renal Cell Carcinoma

Keywords

Renal Cell Carcinoma; Non-Clear Cell; Pemetrexed; Gemcitabine; LY231514; Alimta; MTA; Multitargeted Antifolate; NSC-698037; Gemcitabine Hydrochloride; Gemzar; RCC

Outcome Measures

Primary Outcomes (1)

• Overall Response

  Number of participants with complete or partial response. Response Evaluation Criteria in Solid Tumors (RECIST) of Complete Response: disappearance all target lesions; Partial Response: \>30% decrease in sum of longest diameter (LD) of target lesions, reference baseline sum LD; Progressive Disease: \>20% increase sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of 1 or \> new lesions; Stable Disease: Insufficient shrinkage for partial response, or insufficient increase for progressive disease, reference smallest sum LD since treatment started.

  Baseline to 8 weeks (after 4 cycles) protocol response at 16 weeks

Study Arms (1)

Pemetrexed + Gemcitabine

EXPERIMENTAL

Pemetrexed 500 mg/m\^2 intravenous (IV) and Gemcitabine 1500 mg/m\^2 IV on Day 1.

Drug: Pemetrexed; Drug: Gemcitabine

Interventions

Pemetrexed DRUG

500 mg/m\^2 IV Over 10 Minutes on Day 1.

Also known as: LY231514, Alimta, MTA, Multitargeted Antifolate, NSC-698037

Pemetrexed + Gemcitabine

Gemcitabine DRUG

1500 mg/m\^2 IV Over 30 Minutes on Day 1, Immediately After Infusion of Pemetrexed.

Also known as: Gemcitabine Hydrochloride, Gemzar

Pemetrexed + Gemcitabine

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically or cytologically confirmed advanced non-clear cell RCC. Patients with locally recurrent disease are eligible. Patients with locally advanced unresectable RCC should have measurable metastatic disease to be eligible for the protocol. Patients with bilateral renal cancer are eligible as long as both cancers are of non-clear cell type and patients have metastatic disease.
• Patients must have measurable disease.
• Patients with previously treated or untreated, non-threatening brain metastasis are eligible. For previously treated patients, prior whole brain radiation therapy or stereotactic radiosurgery must be \> 3 months from initiation of current therapy and there can be no plans for concurrent radiation while on this study. Patients who had surgical resection for brain metastasis are eligible to enroll after they recover from surgery.
• Life expectancy \> 8 weeks
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Patients must have adequate organ and marrow function as defined below: (1) Hemoglobin \>/= 9g/dl; (2) absolute neutrophil count \>/= 1,500/microL; (3) platelets \>/=100,000/microL; (4) total bilirubin \</= 1.5 mg/dl; (5) aspartate aminotransferase (AST or SGOT) and/or alanine aminotransferase (ALT or SGPT) (SGPT) \</= 2.5 \* institutional upper limits of normal (uln), or \</= 5 \* uln if liver metastasis exists; (6) creatinine clearance (calculated by the Cockcroft-Gault formula) \>/= 45 mL/min
• Patients must have recovered from any effects of surgery and/or radiation therapy and be free of significant detectable infection.
• Female patients of childbearing potential must have a normal plasma beta human chorionic gonadotropin (bHCG) within 24 hours prior to enrolling in the study. Patients with an elevated bHCG will undergo appropriate evaluation to rule out pregnancy (ie referral to OB-Gyn service, ultrasound) and if pregnancy is ruled out and elevated bHCG is determined to be of tumor origin, patients will be permitted to proceed on study.
• Patients of child fathering or childbearing potential must agree to practice a form of medically acceptable birth control while on study
• Patients must give written consent prior to initiation of therapy, in keeping with the policies of the institution. Patients with a history of major psychiatric illness must be judged able to fully understand the investigational nature of the study and the risks associated with the therapy. The only approved consent is attached to this protocol.

You may not qualify if:

• Pregnant or lactating women.
• No prior malignancy is allowed, except for non-melanoma skin cancer, in situ carcinoma of any site, or other cancers for which the patient has been adequately treated and disease free for 2 years.
• Patients must not have received more than 2 prior systemic therapies for RCC, but patients should not have received any prior chemotherapy for RCC. Chemotherapy given for other types of cancer more than 2 years prior to enrollment on this protocol is permitted.
• Patients must not be scheduled to receive any experimental drug for MRCC while on study. Patients are permitted to be on concomitant bisphosphonates or megestrol acetate. Patients are permitted to receive hematopoietic growth factors according to American Society of Clinical Oncology (ASCO) guidelines.
• Patients must not have had prior radiotherapy to areas of measurable disease, unless they have clearly progressive disease in this site, or there is measurable disease outside the area of prior radiation. Radiotherapy, if needed for palliation, must have been completed prior to enrollment on this study.
• Patients must not have history of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications.
• Patients unwilling to participate or unable to comply with the protocol for the duration of the study.
• Inability or unwillingness to take corticosteroid, folic acid or vitamin B12 supplementation.
• Inability to interrupt aspirin or other non-steroidal anti-inflammatory agents for a 5 day period (for short acting NSAIDs) or 8-day period (for long-lasting NSAIDs, such as piroxicam)

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

UT MD . Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Richey SL, Tamboli P, Ng CS, Lin E, Lim ZD, Araujo JC, Jonasch E, Sharma P, Pagliaro LC, Tannir NM. Phase II trial of pemetrexed plus gemcitabine in patients with locally advanced and metastatic nonclear cell renal cell carcinoma. Am J Clin Oncol. 2013 Oct;36(5):450-4. doi: 10.1097/COC.0b013e3182546a91.

  PMID: 22706175 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Pemetrexed; Gemcitabine

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Quality Assurance Specialist
• Organization: U.T. MD Anderson Cancer Center

guclinicaltrials@mdanderson.org

713-792-2830

Study Officials

• Nizar M. Tannir, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: June 21, 2007
• First Posted: June 25, 2007
• Study Start: December 1, 2005
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: April 24, 2013
• Results First Posted: May 3, 2012

Record last verified: 2013-04

Locations

US (1)