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Phase I/II Open-Label, Dose Escalation Study To Determine The Maximum Tolerated Dose And To Evaluate The Safety Profile of Lenalidomide (Revlimid®) With Liposomal Doxorubicin In Subjects With Advanced Ovarian and Primary Peritoneal Carcinoma


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Female
Ovarian Cancer

Thank you

Trial Information

Phase I/II Open-Label, Dose Escalation Study To Determine The Maximum Tolerated Dose And To Evaluate The Safety Profile of Lenalidomide (Revlimid®) With Liposomal Doxorubicin In Subjects With Advanced Ovarian and Primary Peritoneal Carcinoma


Inclusion Criteria:



1. Subjects must understand and voluntarily sign an informed consent document.

2. Age > or = to 18 years at the time of signing informed consent form.

3. Subjects must be able to adhere to the study visit schedule and other protocol
requirements.

4. Histological or cytological documentation of advanced ovarian or primary peritoneal
carcinoma.

5. Radiographic or clinical evidence of measurable metastatic advanced ovarian or
primary peritoneal carcinoma. Subjects must have measurable disease at least 2 cm in
diameter.

6. Subjects must have been treated and progressed following chemotherapy which includes
platinum and paclitaxel.

7. ECOG performance status of 0 or 1 (Appendix I: ECOG Performance Status Scale).

8. Must have 2-d Echocardiogram/MUGA indicating a LVEF above the institutional lower
limit of normal within 42 days prior to first dose of study drug.

Exclusion Criteria:

1. Any of the following laboratory abnormalities:

1. Absolute neutrophil count (ANC) <1,500 cells/mm3 (1.5 x 109/L)

2. Platelet count <100,000 cells/mm3 (100 x 109/L)

3. Serum creatinine >2.5 mg/dL (221 mmol/L)

4. Serum SGOT/AST or SGPT/ALT >3.0 x upper limit of normal (ULN)

5. Serum total bilirubin >1.2 mg/dL (20 mmol/L)

2. Any serious medical condition or psychiatric illness that places the subject at an
unacceptable risk for study participation or would prevent the subject from signing
the informed consent.

3. Prior history of malignancy (except basal cell or squamous cell carcinoma or
carcinoma in situ of the breast) unless the subject has been free of disease for > or
= to 1 years.

4. Known brain or leptomeningeal disease (CT scan or MRI of the brain required only in
case of clinical suspicion of central nervous system involvement).

5. More than 1 prior chemotherapy regimen. However, subjects with platinum sensitive
disease (i.e., subjects who fail a platinum containing regimen at least six months
after completing the regimen) who are retreated with a platinum containing regimen
are eligible.

6. Concurrent use of any other anti-cancer agents.

7. Any prior use of Lenalidomide.

8. Prior > or = to grade 3 (see Appendix III) allergic reaction/hypersensitivity to
thalidomide.

9. Prior > or = grade 3 (see Appendix III) rash or any desquamating (blistering) rash
while taking thalidomide.

10. Use of any standard or experimental anti-cancer drug therapy within 28 days of the
initiation of study drug therapy.

11. History of cardiac disease, with New York Heart Association Class II or greater (see
Appendix V).

12. Subjects who have received > 200mg/m2 of anthracycline or anthracendione either alone
or in combination. (Additional caution must be taken in subjects with mediastinal
radiation.)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Phase I-To determine the maximum tolerated dose (MTD) and evaluate the safety profile of oral lenalidomide on days 1 – 21 and liposomal doxorubicin on day 1 every 28 days, as combination therapy to subjects with advanced ovarian or primary peritoneal ca

Authority:

United States: Food and Drug Administration

Study ID:

CC-5013-OVRY-001

NCT ID:

NCT00179725

Start Date:

November 2005

Completion Date:

June 2007

Related Keywords:

  • Ovarian Cancer
  • cc-5013
  • revlimid
  • ovarian cancer
  • celgene
  • Carcinoma
  • Ovarian Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
MD Anderson Cancer Center OrlandoOrlando, Florida  32806
Swedish Cancer InstituteSeattle, Washington  98104
University of California at San FranciscoSan Francisco, California  94115
OU Health Sciences CenterOklahoma City, Oklahoma  73104