Phase 2 trial of carboplatin plus tamoxifen in platinum-resistant ovarian cancer and primary carcinoma of the peritoneum.

Abstract

OBJECTIVES:

A previously reported phase 2 trial suggested substantial clinical activity associated with the combination of a platinum agent and tamoxifen in the treatment of platinum-resistant ovarian cancer. We wished to confirm or refute this observation in a patient population with well-characterized platinum-resistant disease.

METHODS:

Patients with ovarian or fallopian tube cancers or primary carcinoma of the peritoneum whose disease had either failed to respond to a platinum-based regimen or had responded but experienced a "treatment-free interval (TFI)" of < or =3 months, or if the TFI was >3 months they had been retreated and failed a platinum-based program, were eligible for entry into this phase 2 single institution protocol. Carboplatin (AUC 5) was delivered on a q-21 day cycle. Tamoxifen was administered at a dose of 80 mg/day for the first cycle, and then reduced to 40 mg/day. Treatment was to be continued until evidence of disease progression or unacceptable toxicity.

RESULTS:

Fourteen patients were treated on this phase 2 trial. In addition to being platinum-resistant, 10 patients had cancers that were also documented to be taxane-resistant (similar criteria to that defined above for platinum). While treatment was generally well tolerated, there were no objective (measurable disease or CA-125 response criteria) or subjective responses to this treatment program.

CONCLUSION:

In this phase 2 trial, we have been unable to confirm a meaningful level of clinical activity for the combination of carboplatin plus tamoxifen in a patient population with well-characterized platinum-resistant ovarian cancer.

• Authors: Maurie Markman, Kenneth Webster, Kristine Zanotti, Gertrude Peterson, Barbara Kulp, Jerome Belinson
• Journal: Gynecologic oncology (Gynecol Oncol) Vol. 94 Issue 2 Pg. 404-8 (Aug 2004) ISSN: 0090-8258 [Print] United States
• PMID: 15297180 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article)

Chemical References

• Tamoxifen
• Carboplatin
• Cisplatin

Topics

• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Carboplatin (administration & dosage, adverse effects, pharmacology)
• Cisplatin (pharmacology)
• Drug Resistance, Neoplasm
• Drug Synergism
• Fallopian Tube Neoplasms (drug therapy)
• Female
• Humans
• Middle Aged
• Ovarian Neoplasms (drug therapy)
• Peritoneal Neoplasms (drug therapy)
• Tamoxifen (administration & dosage, adverse effects)