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Recurrent Renal Cell CarcinomaPhase 1/2NCT00121251

Sorafenib, Gemcitabine, and Capecitabine in Treating Patients With Unresectable and/or Metastatic Kidney Cancer

A Phase 1/2 study testing Capecitabine, Gemcitabine Hydrochloride and Sorafenib Tosylate in people with Recurrent Renal Cell Carcinoma and Stage III Renal Cell Cancer AJCC v7, run by National Cancer Institute (NCI) at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase I/II trial is studying the side effects and best dose of sorafenib, gemcitabine, and capecitabine and to see how well they work in treating patients with unresectable and/or metastatic kidney cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Capecitabine, Gemcitabine Hydrochloride and Sorafenib Tosylate
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
4 sitesUnited States
Study dates
3 Jun 2005to 14 Mar 2017
Phase
Phase 1/2
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have histologically or cytologically confirmed renal cell carcinoma that is unresectable and/or metastatic; patients with collecting duct carcinoma, oncocytomas, or transitional cell carcinoma are not eligible; patients with sarcomatoid renal cell carcinoma are eligible, but those with pure sarcomas are not; histologic documentation of metastatic disease is not required; clinical confirmation, but not pathologic staging, of metastatic disease is required
  • Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan
  • Patients may have received one prior immunotherapy based regimen (i.e. interleukin-2 or interferon alpha) ending >= 4 weeks prior to enrollment
  • Patients may have received up to 2 prior regimens containing mitogen-activated protein kinases (MAPK), vascular endothelial growth factor (VEGF) pathway inhibitors (e.g. sunitinib or bevacizumab) and/or mammalian target of rapamycin (mTOR) inhibitor (e.g. temsirolimus) ending >= 4 weeks prior to enrollment
  • Life expectancy of more than 3 months
  • Eastern Cooperative Oncology Group (ECOG) =< 2 OR Karnofsky >= 60%
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  • Leukocytes >= 3000/uL
  • Absolute neutrophil count >= 1,500/uL
  • Platelet count >= 100,000/uL
  • Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) =< 2.5 x IULN
  • Creatinine =< 1.5 x IULN OR creatinine clearance >= 60 mL/min/1.73m^2 for patients with creatinine levels above institutional normal
  • The effects of sorafenib on the developing human fetus at the recommended therapeutic dose are unknown; for this reason and because raf kinase inhibitor agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
  • Ability to understand and the willingness to sign a written informed consent document

Who cannot join

  • Patients may not have received prior chemotherapy; if patients have had prior definitive or other surgery, prior radiation therapy, they must have fully recovered from the effects of therapy with at least 4 weeks recovery time; for patients who have had a surgical biopsy only, they must have simply recovered
  • Patients may not be receiving any other investigational agents
  • Patients with known active brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events; previously treated brain metastases are allowed if they show no evidence of progression on CT or magnetic resonance imaging (MRI) at least 8 weeks after completion of surgery and/or radiotherapy
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to sorafenib, gemcitabine and capecitabine
  • No concurrent megestrol is permitted; no megestrol therapy within 4 weeks prior to protocol treatment is allowed; no concurrent cytochrome P450 enzyme-inducing antiepileptic drugs (phenytoin, phenobarbitol or carbamazepine), rifampin, or St. John's wort
  • Uncontrolled intercurrent illness including, but not limited to, uncontrolled hypertension, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, pulmonary disease including asthma, chronic bronchitis, emphysema with requirements for chronic oxygen use or psychiatric illness/social situations that would limit compliance with study requirements
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  • Pregnant women are excluded from this study because sorafenib is a kinase inhibitor agent with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with sorafenib, breastfeeding should be discontinued if the mother is treated with sorafenib; the potential risks may apply to other agents used in this study
  • Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, human immunodeficiency virus (HIV)-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with sorafenib, gemcitabine, or capecitabine administered during the study; appropriate studies will be undertaken in patients receiving combination ant-retroviral therapy when indicated
  • Any swallowing dysfunction leading to difficulty taking the investigational therapy or capecitabine
  • Prior treatment with sorafenib
  • Patients with any history or evidence of a bleeding diathesis
  • Patients on therapeutic anticoagulation with coumarins (e.g. warfarin); prophylactic coumarin-based anticoagulation (i.e. low dose warfarin) for venous or arterial access devices is allowed provided that the requirements for prothrombin time (PT), international normalization ratio (INR) and/or partial thromboplastin time (PTT) are met; prophylactic or therapeutic low molecular weight heparin is allowed; patients with known brain metastases are excluded (even if treated and stable) if they are also on therapeutic doses of anticoagulation
  • Patients with known dihydropyrimidine dehydrogenase deficiency

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    New York, New York, 10016

  • Mount Sinai Hospital

    New York, New York, 10029

  • Weill Medical College of Cornell University

    New York, New York, 10065

  • Montefiore Medical Center - Moses Campus

    The Bronx, New York, 10467

Other trials in United States

About this study

Official title: A Phase I/II Trial of BAY 43-9006 Plus Gemcitabine and Capecitabine in the Treatment of Patients With Advanced Renal Cell Carcinoma

This phase I/II trial is studying the side effects and best dose of sorafenib, gemcitabine, and capecitabine and to see how well they work in treating patients with unresectable and/or metastatic kidney cancer. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with gemcitabine and capecitabine may kill more tumor cells.

Read the detailed description

OBJECTIVES:

  1. Determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of sorafenib administered in combination with gemictabine and capecitabine in patients with advanced renal cell carcinoma.

II. Determine the objective response rate for sorafenib in combination with gemictabine and capecitabine in patients with advanced renal cell carcinoma.

III. Determine the duration of overall survival and progression free survival in these patients.

OUTLINE: This is a multicenter, non-randomized, phase I dose-escalation study followed by a phase II study.

PHASE I: Patients receive sorafenib* orally (PO) twice daily (BID) on days 1-21, gemcitabine intravenously (IV) over 30 minutes on days 1 and 8, and capecitabine PO BID on days 1-14. Treatment repeats every 21 days for at least 3 courses in the absence of unacceptable toxicity or disease progression.

Cohorts of 3-6 patients receive escalating doses of sorafenib, gemcitabine, and capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. An additional 6 patients are treated at the MTD.

Note: *Patients who complete at least 3 courses of treatment with objective response or stable disease but are deemed poor candidates for continued chemotherapy may continue treatment with sorafenib

PHASE II: Patients receive sorafenib 200mg orally twice a day on days 1-21, gemcitabine 750 mg/m2 intravenously on days 1 \& 8, and capecitabine 415 mg/m2 orally twice a day on days 1-14 of each 21 day cycle, as in phase I at the MTD determined in phase I.

After completion of study treatment patients are followed periodically.

Being tested
Capecitabine, Gemcitabine Hydrochloride, Sorafenib Tosylate
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.

  • CapecitabineDrug

    Also called Ro 09-1978/000, Xeloda

    Given PO

  • Gemcitabine HydrochlorideDrug

    Also called dFdCyd, Difluorodeoxycytidine Hydrochloride, Gemzar, LY-188011

    Given IV

  • Sorafenib TosylateDrug

    Also called BAY 43-9006 Tosylate, BAY 54-9085, Nexavar, sorafenib

    Given PO

Study groups in NCT00121251
Study groupRoleWhat they receive
Sorafenib + Gemcitabine + CapecitabineExperimentalPatients receive sorafenib* PO BID on days 1-21, gemcitabine IV over 30 minutes on days 1 and 8, and capecitabine PO BID on days 1-14. Treatment repeats every 21 days for at least 3 courses in the absence of unacceptable toxicity or disease progression.
Receives: Drug: Capecitabine; Drug: Gemcitabine Hydrochloride; Drug: Sorafenib Tosylate

What is being measured

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

  1. Objective Response for BAY 43-9006 in Combination With Gemcitabine and Capecitabine Evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST)

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR

    Measured: Up to 9 years

Secondary outcomes (2)

  1. Median Number of Months of Progression Free Survival (PFS)

    PFS will be measured from the time of the patient's initial best response (PR or CR) until documented progression.

    Measured: From the time of the patient's initial best response (PR or CR) until documented progression, assessed up to 9 years

  2. Number of Participants Who Survived (Overall Survival)

    Overall survival (OS) is defined as the time from start of treatment to death from any cause.

    Measured: Up to 9 years

Timeline

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

  1. First posted21 Jul 2005 (estimated)
  2. Study start3 Jun 2005
  3. Primary completion14 Mar 2017
  4. Study completion14 Mar 2017

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00121251
Sponsor's protocol ID
NCI-2009-00108
Other IDs
NCI-2009-00108, CDR0000434851, 0501007709, 6981, N01CM62204, P30CA013330
Status last verified
Mar 2021
First submitted
19 Jul 2005
Last updated
6 Apr 2021

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Capecitabine, Gemcitabine Hydrochloride and Sorafenib Tosylate in people with Recurrent Renal Cell Carcinoma and Stage III Renal Cell Cancer AJCC v7, run by National Cancer Institute (NCI) at 4 sites 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 14 inclusion and 13 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: finished, as of the sponsor's last update on 6 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 6 Apr 2021). 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?

Objective Response for BAY 43-9006 in Combination With Gemcitabine and Capecitabine Evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST) (time frame: Up to 9 years). 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 NCT00121251.

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 6 Apr 2021.

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