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Renal Cell CarcinomaPhase 2NCT00491075

Pemetrexed Plus Gemcitabine in Renal Cell Cancer

A Phase 2 study testing Pemetrexed and Gemcitabine in people with Renal Cell Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Renal Cell Carcinoma
What is being tested?
Pemetrexed and Gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteUnited States
Study dates
Dec 2005to Sep 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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 any significant medical disease (other than the malignancy) that, in the opinion of the investigator, would significantly increase the risk for participation in this trial. Examples of exclusion: unstable angina pectoris, New York Heart Association (NYHA) Grade II or greater congestive heart failure, unstable symptomatic cardiac arrhythmias requiring medication (subjects with controlled chronic atrial fibrillation are eligible), myocardial infarction within the last 6 months, uncontrolled hypertension (blood pressure >160/110 on therapy) or uncontrolled diabetes mellitus.
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  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UT MD . Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Phase II Trial of Pemetrexed Plus Gemcitabine in Patients With Advanced Non-Clear Cell Renal Cell Cancer

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.
Read the detailed description

Pemetrexed is a chemotherapy drug that is used to treat cancer. It is given intravenously (by IV--through a vein in your arm). It interferes with cell reproduction.

Gemcitabine is a cancer-fighting (chemotherapy) drug that is given by IV. It interferes with the growth of cells and is used to treat cancer.

Dexamethasone has many different medical uses. It is used to treat cancer, nausea, vomiting, inflammation, allergic reactions, and many other conditions. In this study, it is being given to prevent rashes.

Folic acid and Vitamin B12 are vitamins given to prevent serious side effects which can occur with chemotherapy. These side effects include diarrhea and a decrease in you red blood cells, white blood cells, and your blood platelets.

You will be required to take folic acid and vitamin B12. You will take folic acid, by mouth, daily beginning about 1 week before the first dose of Pemetrexed. You will continue to take it daily until 3 weeks after the last dose of chemotherapy. Vitamin B12 will be given as an injection into your muscle about 1 to 2 weeks before your first dose of Pemetrexed. You will have injections of vitamin B12 about every 9 weeks until 3 weeks after your last dose of chemotherapy.

During treatment, you will be given Pemetrexed by IV for 10 minutes, followed by Gemcitabine by IV for 30 minutes on Day 1 of each 2-week study "cycle."

You will take Dexamethasone tablets by mouth, 2 times a day on the day before, the day of, and the day after each dose of Pemetrexed. Dexamethasone is taken to prevent rashes. If you could not or did not take Dexamethasone the day before and/or the day of Pemetrexed, you may be given Dexamethasone by IV over 20 minutes, 30 minutes before the infusion of Pemetrexed.

You will have blood samples (about 4 teaspoons) drawn every week to test your bone marrow. You will have blood samples (about 1 teaspoon) drawn every 2 weeks to make sure that your kidneys and liver are working well. You will have a physical exam every 2 weeks before you receive chemotherapy. You will also be asked about any medications you have been taking since your last visit.

Once every 8 weeks or after 4 cycles of treatment, you will have the tumor(s) measured using standard of care imaging which may include a CT scan, MRI, or a bone scan.

You will be treated for as long as you are benefiting from the therapy. You will continue to receive treatment unless your tumor grows, intolerable side effects occur, or you develop another illness that prevents you from continuing with the therapy. You may also be taken off study if you fail to comply with the study requirements. If you are taken off study for any reason, you and your doctor will discuss other treatment options at that time.

If you are taken off study, you will be asked to have the same scans as before, a physical exam, and routine blood (about 4 teaspoons). You will be contacted every 3 months after being off study, to get an update on your health status.

This is an investigational study. Pemetrexed and Gemcitabine are FDA approved and commercially available. About 40 patients will take part in this study. All will be enrolled at M. D. Anderson.

Being tested
Pemetrexed, Gemcitabine
Keywords
Renal Cell Carcinoma, Non-Clear Cell, Pemetrexed, Gemcitabine, LY231514, Alimta, MTA, Multitargeted Antifolate, NSC-698037, Gemcitabine Hydrochloride, Gemzar, RCC
Medical subject headings
Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PemetrexedDrug

    Also called LY231514, Alimta, MTA, Multitargeted Antifolate

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

  • GemcitabineDrug

    Also called Gemcitabine Hydrochloride, Gemzar

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

Study groups in NCT00491075
Study groupRoleWhat they receive
Pemetrexed + GemcitabineExperimentalPemetrexed 500 mg/m^2 intravenous (IV) and Gemcitabine 1500 mg/m^2 IV on Day 1.
Receives: Drug: Pemetrexed; Drug: Gemcitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2007 (estimated)
  2. Study startDec 2005
  3. Primary completionSep 2011
  4. Study completionSep 2011

Why it stopped: Closed early for poor accrual.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00491075
Sponsor's protocol ID
2005-0516
Status last verified
Apr 2013
First submitted
21 Jun 2007
Last updated
24 Apr 2013
Data monitoring committee
No

Publications

  • 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.

    PubMed 22706175

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pemetrexed and Gemcitabine in people with Renal Cell Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 24 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response (time frame: Baseline to 8 weeks (after 4 cycles) protocol response at 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00491075, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2013.

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