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Gemcitabine, Carboplatin, and Lenalidomide for Treatment of Advanced/Metastatic Urothelial Cancer and Other Solid Tumors

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ClinicalTrials.gov Identifier: NCT01352962
Recruitment Status : Active, not recruiting
First Posted : May 12, 2011
Last Update Posted : October 19, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:


- Gemcitabine and carboplatin are chemotherapy drugs used to treat several types of cancer, including cancer of the pancreas, bladder, ovaries, and lung. Lenalidomide, a drug that prevents the growth of new blood vessels in tumors, has been approved for treatment of certain blood cancers, but it has not yet been approved for use in combination with gemcitabine and carboplatin. Researchers are interested in determining the safest and most effective dose of this combined form of chemotherapy for solid tumors, particularly for urothelial cancer (tumors of the bladder, urethra, ureter, or renal pelvis).


  • To evaluate the safety and effectiveness of combined lenalidomide, gemcitabine, and carboplatin as a treatment for solid tumor cancers.
  • To evaluate the safety and effectiveness of combined lenalidomide, gemcitabine, and carboplatin as a treatment for urothelial (bladder) cancer.


  • Individuals at least 18 years of age who have been diagnosed with solid tumors that have not responded to standard treatments.
  • Individuals at least 18 years of age who have been diagnosed with urothelial cancer that has not responded to standard treatments.


  • Participants will be screened with a physical examination, medical history, blood tests, and tumor imaging studies.
  • Participants with urothelial cancer will receive lenalidomide alone for the first 14 days of a 21-day cycle before starting the first full treatment cycle.
  • All participants will receive gemcitabine on days 1 and 8, and carboplatin on day 1 only, of every 21-day treatment cycle. Lenalidomide will be taken daily at home for the first 14 days of each cycle. Participants will be asked to take aspirin or other medications to prevent the possibility of blood clots.
  • Participants may receive up to six cycles of treatment with this combination. If after six cycles the cancer has not grown or has shrunk, participants may continue to take lenalidomide alone for an additional 6 months (total of 12 months of therapy) or until the cancer recurs.
  • Participants will be monitored with blood samples, physical examinations, and tumor imaging studies through the cycles of treatment.
  • After the end of the last treatment cycle, participants will have followup visits every 3 months for the next 18 months, then every 6 months for another 18 months, and then yearly....

Condition or disease Intervention/treatment Phase
Urethral Neoplasms Neoplasms, Urethral Ureter Cancer Cancer of the Urethra Urethral Cancer Drug: Gemcitabine Drug: Carboplatin Drug: Lenalidomide Phase 1

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Gemcitabine, Carboplatin and Lenalidomide (GCL) for Treatment of Patients With Advanced/Metastatic Urothelial Carcinoma (UC) and Other Solid Tumors
Study Start Date : May 11, 2011
Primary Completion Date : February 7, 2017
Estimated Study Completion Date : August 1, 2020

Arms and Interventions

Arm Intervention/treatment
Experimental: Arm 1
Standard of Care plus escalating dosesof Lenalidomide
Drug: Gemcitabine
1,000mg/m2 IVPB over 30 min x 1
Drug: Carboplatin
AUC 5** IVPB over 30 min x 1
Drug: Lenalidomide
Escalating Doses starting at 2.5 po daily up to 25 mg po daily until MTD is reached.

Outcome Measures

Primary Outcome Measures :
  1. Dose limiting toxicity [ Time Frame: Maximum Tolerated Dose ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Dose Escalation cohort only

- Adult patients with histologic documentation of an advanced solid tumor for whom gemcitabine and carboplatin would be appropriate first line therapy, including but not limited to urothelial cancer, non-small cell lung cancer, pancreatic and ovarian carcinoma.

Expansion cohort only

Patients must have a histologically confirmed diagnosis of urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis. Confirmation may be obtained from any CLIA certified lab.


-Patient must have a histologically confirmed diagnosis of non-transitional cell carcinoma of the bladder, urethra, ureter, or renal pelvis including but not limited to squamous cell, neuroendocrine, adenocarcinoma including urachal and sarcomatoid. Confirmation may be obtained from any CLIA certified lab.

All patients

  • Unresectable or metastatic disease
  • Urothelial cancer patients should be ineligible for cisplatin based on one or more of the following:
  • Calculated creatinine clearance of < 60 mL/min (but greater than or equal to 30 mL/min)
  • Solitary kidney
  • Karnofsky Performance Status < 80%
  • Age greater than or equal to 18 years of age; UC is not a common cancer in children and without proven benefit, this combination of chemotherapy agents presents too great a risk for conducting as a phase I study in children.
  • Karnofsky Performance Status greater than or equal to 60%
  • Required Initial Laboratory Values:
  • Absolute neutrophil count greater than or equal to 1.2 x 10(9)/L
  • Platelets greater than or equal to 100 x 10(9)/L
  • Bilirubin less than or equal to 1.5 times the upper limit of normal for the institution or less than or equal to 3 mg/dl in a subject with Gilbert Syndrome
  • Aspartate transaminase (AST) and alanine transaminase (ALT) less than or equal to 3 times the ULN for the institution (less than or equal to 5 times the ULN is acceptable if liver has tumor involvement).
  • Serum creatinine < 2 or calculated creatinine clearance (CrCl) greater than or equal to 30 mL/min
  • Ability to understand and willingness to sign the written informed consent document.
  • Patients must be able to swallow whole capsules. Capsules must not be crushed or chewed; capsules must not be opened.


  • For urothelial cancer patients, no prior combination systemic chemotherapy for metastatic disease, except:
  • Single-agent radiosensitizing chemotherapy is not considered prior systemic therapy
  • Prior neoadjuvant or adjuvant systemic chemotherapy (including cisplatin-based) is allowed provided it was completed greater than or equal to 6 months prior to the diagnosis of metastatic disease
  • Prior intravesical therapy is permitted
  • For non-urothelial cancer patients, no more than 1 prior line of combination systemic chemotherapy for metastatic disease is allowed
  • Less than or equal to 2 weeks since radiation therapy
  • Unstable angina
  • New York Heart Association (NYHA) Grade II or greater congestive heart failure
  • History of myocardial infarction within 6 months
  • History of stroke within 6 months
  • Clinically significant peripheral vascular disease
  • Evidence of bleeding diathesis or coagulopathy. Patients that are on anticoagulation therapy for DVT will be allowed to enroll and continue on the treatment dose of enoxaparin or other anticoagulation such a warfarin.
  • Patients with contraindications to anticoagulation therapy for deep venous thrombosis such as:
  • Patients on full treatment dose of anticoagulation such as those patients being treated for a deep vein thrombosis or pulmonary embolus.
  • Presence of central nervous system or brain metastases
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1
  • Anticipation of need for major surgical procedure during the course of the study

Those patients that develop DVTs during the study will be treated with anticoagulants and in certain cases, will continue on the protocol.

  • Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10 14 days and again within 24 hours prior to starting Cycle 1 of lenalidomide. Further, they must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control: one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before starting lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP, even if they have had a successful vasectomy. A FCBP is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months). All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure.
  • Inability to comply with study and/or follow-up procedures
  • Patients may not be receiving any other investigational agents
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to lenalidomide, gemcitabine or carboplatin, or other agents used in study.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Due to the possibility of infection reactivation, patients who are known seropositive for or who have active viral infection with human immunodeficiency virus (HIV) are NOT eligible.


Both men and women of all races and ethnic groups are eligible for this trial.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01352962

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
Principal Investigator: Andrea B Apolo, M.D. National Cancer Institute (NCI)
More Information

Additional Information:
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01352962     History of Changes
Other Study ID Numbers: 110140
First Posted: May 12, 2011    Key Record Dates
Last Update Posted: October 19, 2017
Last Verified: August 4, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Dose Limiting Toxicity
Urethra Cancer
Carcinoma of the Bladder
Cancer of the Renal Pelvis
Ureter Cancer
Urethral Cancer
Solid Tumor
Pancreatic Cancer
Ovarian Cancer
Non-Small Cell Lung Cancer

Additional relevant MeSH terms:
Urethral Neoplasms
Ureteral Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urethral Diseases
Urologic Diseases
Ureteral Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Leprostatic Agents
Anti-Bacterial Agents