AzTrials
AzTrials

Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00415116

Lenalidomide, Docetaxel, and Carboplatin in Treating Patients With Advanced Solid Tumors

A Phase 1 study testing carboplatin, docetaxel and lenalidomide in people with Unspecified Adult Solid Tumor, Protocol Specific, run by The Cleveland Clinic.

Completed

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

Official record
Search all trials

Trial summary

RATIONALE: Lenalidomide may stop the growth of solid tumors by blocking blood flow to the tumor. Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
carboplatin, docetaxel and lenalidomide
How many people
14 participants
Where
No sites listed yet
Study dates
Aug 2004to Jul 2007
Phase
Phase 1
Are there results?
None posted in the registry

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

DISEASE CHARACTERISTICS:

  • Histologically or cytologically proven solid tumor
  • Measurable or evaluable disease
  • Refractory to standard treatment
  • No prior failure of a docetaxel and carboplatin regimen except in the adjuvant setting
  • History of brain disease allowed, provided the following criteria are met:
  • Brain disease previously treated with radiotherapy or surgery
  • Asymptomatic with no active brain disease, as documented by CT scan or MRI, for at least 3 months

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Creatinine ≤ 1.5 mg/dL
  • Bilirubin normal
  • AST and ALT ≤ 2 times upper limit of normal (ULN) (5 times ULN if hepatic metastases are present)
  • Alkaline phosphatase ≤ 3 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 4 weeks after completion of study treatment
  • No serious medical condition, laboratory abnormality, or psychiatric illness that would preclude giving informed consent, expose the patient to unacceptable risk, or affect the interpretation of study data
  • No known hypersensitivity to thalidomide
  • No history of erythema nodosum, characterized by a desquamating rash, while taking thalidomide or similar drugs
  • No pre-existing peripheral neuropathy ≥ grade 2
  • No known hypersensitivity or intolerance to taxanes
  • No known HIV positivity
  • No known infectious hepatitis, types A, B, or C

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No more than 2 prior chemotherapy regimens
  • At least 28 days since prior cancer therapy, including radiotherapy, biologic therapy, hormonal therapy, chemotherapy, or surgery
  • At least 28 days since any other prior investigational drug or therapy
  • No prior lenalidomide
  • No other concurrent chemotherapy or biologic therapy
  • No concurrent radiotherapy
  • No concurrent use of any other anticancer agents or treatments
  • No prophylactic granulocyte colony-stimulating factors (G-CSF) during the first course of study treatment
  • No concurrent prophylactic antibiotics
  • No concurrent treatment with the following medications:
  • Systemic corticosteroids (except as prophylaxis for docetaxel administration)
  • Estrogens
  • Azoles
  • Macrolides
  • Cyclosporine
  • Rifampin
  • Phenytoin

About this study

Official title: Phase I Trial of Three-Weekly Docetaxel, Carboplatin and Oral CC-5013 in Patients With Advanced Solid Tumors

RATIONALE: Lenalidomide may stop the growth of solid tumors by blocking blood flow to the tumor. Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with docetaxel and carboplatin may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of lenalidomide when given together with docetaxel and carboplatin in treating patients with advanced solid tumors.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the maximum tolerated dose of lenalidomide when administered with docetaxel and carboplatin in patients with advanced solid tumors.

Secondary

  • Determine the safety and toxic effects of this regimen in these patients.
  • Determine, preliminarily, the clinical activity of this regimen in these patients.

OUTLINE: This is an open-label, dose-escalation study of lenalidomide.

Patients receive docetaxel IV over 1 hour followed by carboplatin IV on day 1. Patients also receive oral lenalidomide once daily on days 1-14. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease after completion of 6 courses of treatment may continue lenalidomide alone once daily on days 1-14. Patients whose disease is stable or responding after completing 2 or 4 courses and who are unable to tolerate further chemotherapy may continue lenalidomide alone once daily on days 1-14, at the investigator's discretion. Treatment with lenalidomide repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of lenalidomide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional 6-8 patients are treated at the MTD.

After completion of study treatment, patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.

Keywords
unspecified adult solid tumor, protocol specific

What participants receive

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

What is being measured

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

  1. Maximum tolerated dose of lenalidomide

  2. Dose-limiting toxicity of lenalidomide

Secondary outcomes (2)
  1. Safety and toxicity

  2. Clinical activity

Timeline

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

  1. First posted22 Dec 2006 (estimated)
  2. Study startAug 2004
  3. Primary completionJul 2007
  4. Study completionJul 2007

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00415116
Sponsor's protocol ID
CASE-CCF-7216
Other IDs
P30CA043703, CASE-CCF-7216
Status last verified
Nov 2006
First submitted
21 Dec 2006
Last updated
8 Jul 2011
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing carboplatin, docetaxel and lenalidomide in people with Unspecified Adult Solid Tumor, Protocol Specific, run by The Cleveland Clinic.

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

Who may be eligible to take part?

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 8 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.

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 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.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Maximum tolerated dose of lenalidomide. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 8 Jul 2011.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in