Clinical trial NCT00041080 (phase 3, status: completed)
Conditions: fallopian tube cancer, primary peritoneal cavity cancer, recurrent ovarian epithelial cancer, stage iii ovarian epithelial cancer, stage iv ovarian epithelial cancer
ICD codes: C57.00, C57.01, C57.02, C30.0, Z12.81, D14.0, C14.8, D37.09, Z86.003, Z85.818, H18.523, H18.521, H18.522, H18.529, H18.523, H18.521, H18.522, H18.529, H18.523, H18.521, H18.522, H18.529
Drugs: tamoxifen citrate, thalidomide
SMILES: COC1=CC(NCC2=C(C)C3=C(C=C2)N=C(N)N=C3N)=CC(OC)=C1OC, CC(C)NCC(O)COC1=CC=CC2=C1C=CC=C2
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed stage III or IV ovarian epithelial, fallopian tube, or
             primary peritoneal cancer that was treated with only 1 prior first-line chemotherapy
             regimen (platinum/taxane-based)

          -  Clinically and radiologically without evidence of measurable and nonmeasurable disease

               -  Symptomatic ascites and pleural effusions are considered nonmeasurable disease

          -  Must have a biochemical recurrence

               -  CA 125 must have been normal prior to or normalized during first-line therapy and
                  then subsequently rose to exceed twice the upper limit of normal

               -  Patients entering study with a CA 125 level less than 100 U/mL must be confirmed
                  a second time within a period of not more than 4 weeks

               -  Patients with a CA 125 level of at least 100 U/mL may be entered without
                  confirmatory measurement

          -  Ineligible for a higher priority Gynecologic Oncology Group protocol (if one exists)

          -  No history of brain metastases

          -  Performance status - GOG 0-1

          -  Absolute neutrophil count at least 1,500/mm^3

          -  Platelet count at least 100,000/mm^3

          -  Bilirubin no greater than 1.5 times upper limit of normal (ULN)

          -  SGOT no greater than 2.5 times ULN

          -  Alkaline phosphatase no greater than 2.5 times ULN

          -  Creatinine no greater than 1.5 times ULN

          -  Creatinine clearance at least 60 mL/min

          -  No history of deep venous thrombosis

          -  No prior cerebrovascular accident

          -  No history of pulmonary embolism

          -  No significant infection

          -  No grade 2 or greater sensory or motor neuropathy

          -  No other malignancy within the past 5 years except nonmelanoma skin cancer or
             carcinoma in situ

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use at least 1 highly active method and at least 1 additional
             effective method of contraception for 4 weeks before, during, and for 4 weeks after
             study participation

          -  No prior immunotherapy (e.g., interleukins)

          -  No prior biological response modifiers (e.g., monoclonal antibodies)

          -  No prior antiangiogenic agents (e.g., carbonic anhydrase inhibitors)

          -  At least 3 weeks since prior anticancer chemotherapy and recovered

          -  No prior or concurrent tamoxifen or other selective estrogen receptor modulators

          -  At least 4 weeks since prior and no concurrent hormones (e.g., estrogen or
             progesterone)

          -  At least 3 weeks since prior anticancer radiotherapy and recovered

          -  At least 3 weeks since prior anticancer surgery and recovered

          -  Prior second-look surgery without cytoreduction allowed

          -  At least 3 weeks since other prior anticancer therapy and recovered

          -  No prior interval cytoreduction

          -  No concurrent full-dose therapeutic anticoagulation

          -  No concurrent antiseizure medications for seizure disorder

          -  No concurrent bisphosphonates (e.g., zoledronate)