Phase 2 N=59 Treatment

Chemoimmunotherapy Study for Patients With Epithelial Ovarian Cancer

Ovarian Cancer · Fallopian Tube Cancer · Peritoneal Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00501644 ↗

Enrolled (actual)

Serious AEs

37.0%

Results posted

Jan 2011

Primary outcome: Primary: Number of Patients With Response — 9; 21; 24 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Carboplatin (Drug); GM-CSF (Sargramostim) (Drug); Interferon Gamma (Drug)
Age: Pediatric, Adult, Older Adult
Sex: Female
Sponsor: M.D. Anderson Cancer Center
Primary completion: Jan 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Patients With Response	9; 21; 24	—

Summary

Primary Objectives: 1. Determine response rate, time to progression, and toxicity of a schedule of carboplatin by IV (intravenous) infusion, GM-CSF and rIFN-g by SC (subcutaneous injection) in patients with potentially platinum-sensitive recurrent Müllerian carcinomas. 2. Determine whether this treatment schedule is associated with: 1. increased levels of monocytes (>2-fold and absolute numbers 1000 cells/ml,) and of LN-DR+ DC (CD11c+ and CD123+ subsets) 2. induction of priming and activation of MO/MA (monocytes/ macrophages), and maturation of DC (dendritic cells). 3. Determine the toxicity profile of consolidation treatment with IP (intraperitoneal) injections of rIFN-g added to carboplatin (IV) and GM-CSF (SC) for 4 doses/course. 4. Determine the effects of carboplatin plus GM-CSF and rIFN-g on quality of life in patients with platinum-sensitive Müllerian carcinomas. 5. To begin an exploration of cell surface proteins on purified activated peripheral blood and ascites monocyte/macrophages both before and after treatment with GM-CSFand rIFN-g.

Eligibility Criteria

Inclusion Criteria

Patients with Müllerian carcinomas (primary epithelial ovarian, primary peritoneal, or fallopian tube) who have had a response to platinum-based chemotherapy and have a chemotherapy treatment-free interval of at least 6 months. These patients are designated potentially platinum-sensitive.
Measurable disease by radiological or clinical examination parameters.
No prior immunotherapy.
No concurrent steroids or radiation therapy.
Adequate hematological parameters (ANC >/= 1500 cells/UL, platelets >/= 100,000 cells/UL
Adequate renal function (serum creatinine 10% over 4 months
Radiation therapy to whole abdomen
History of clinical or EKG findings suggestive of active (within the last 6 months) heart disease
Patients with active autoimmune or inflammatory bowel disease
Patients with an active serious infection or other serious underlying medical condition that would otherwise impair their ability to receive protocol treatment.
Dementia or significantly altered mental status that would prohibit the understanding and/or giving of informed consent.
Patients with prior hypersensitivity to platinum agents
Patients with history of other malignancy, with the exception of non-melanomatous skin cancer; unless in complete remission and off therapy for a minimum of 5 years.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00501644). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.