Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

RATIONALE: Drugs used in chemotherapy, such as elesclomol sodium and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving elesclomol together with paclitaxel may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects of giving elesclomol sodium together with paclitaxel and to see how well it works in treating patients with recurrent or persistent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.

Further Study Information

OBJECTIVES:

Primary

• To estimate the antitumor activity of elesclomol sodium and paclitaxel, in terms of the frequency of objective tumor responses, in patients with persistent or recurrent platinum-resistant ovarian epithelial, fallopian tube, or primary peritoneal cancer.

• To determine the nature and degree of toxicity of elesclomol sodium and paclitaxel in these patients.

Secondary

• To estimate the progression-free survival and overall survival of these patients.

OUTLINE: This is a multicenter study.

Patients receive elesclomol sodium IV over 1 hour and paclitaxel IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal carcinoma, including any of the following epithelial cell types:

• Serous adenocarcinoma

• Endometrioid adenocarcinoma

• Mucinous adenocarcinoma

• Undifferentiated carcinoma

• Clear cell adenocarcinoma

• Mixed epithelial carcinoma

• Transitional cell carcinoma

• Malignant Brenner tumor

• Adenocarcinoma not otherwise specified

• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 10 mm by CT scan, MRI, or caliper measurement by clinical exam or ≥ 20 mm by chest x-ray

• Lymph nodes must be ≥ 15 mm in short axis by CT scan or MRI

• Must have ≥ 1 target lesion to assess response as defined by RECIST 1.1 criteria

• Tumors within a previously irradiated field will be designated as "non-target" lesions unless there is documented disease progression or a biopsy is obtained to confirm persistence ≥ 90 days after completion of radiotherapy

• Must have received 1 prior platinum-based chemotherapeutic regimen containing carboplatin, cisplatin, or another organoplatinum compound for management of the primary disease

• Initial treatment may have included intraperitoneal therapy, high-dose therapy, consolidation therapy, non-cytotoxic therapy, or extended therapy administered after surgical or non-surgical assessment

• No additional cytotoxic chemotherapy for management of recurrent or persistent disease, including re-treatment with initial chemotherapy regimens

• One additional non-cytotoxic regimen for management of recurrent or persistent disease allowed

• Must be considered platinum-resistant or refractory according to standard GOG criteria (i.e., treatment-free interval of < 6 months after completion of platinum-based therapy OR progressed during platinum-based therapy)

• Not eligible for a higher priority GOG protocol

PATIENT CHARACTERISTICS:

• GOG performance status 0-2

• ANC ≥ 1,500/mcL

• Platelet count ≥ 100,000/mcL

• Creatinine ≤ 1.5 times upper limit of normal (ULN)

• Bilirubin ≤ 1.5 times ULN

• SGOT ≤ 3.0 times ULN

• Alkaline phosphatase ≤ 2.5 times ULN

• LDH levels ≤ 0.8 times ULN

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No neuropathy (sensory and motor) > grade 1 by CTCAE criteria

• No active infection requiring antibiotics, except uncomplicated urinary tract infection

• No other invasive malignancies within the past 5 years, except nonmelanoma skin cancer or other specific malignancies

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• Recovered from prior surgery, radiotherapy, or chemotherapy

• At least 1 week since prior hormonal therapy directed at the malignant tumor

• At least 3 weeks since prior biological therapy, immunotherapy, or other therapy directed at the malignant tumor

• No prior radiotherapy to > 25% of marrow-bearing areas

• No prior radiotherapy to any portion of the abdominal cavity or pelvis, except for the treatment of ovarian, fallopian tube, or primary peritoneal cancer

• Prior radiotherapy for localized cancer of the breast, head and neck, or skin allowed provided it was completed > 3 years ago and the patient remains free of recurrent or metastatic disease

• No prior chemotherapy for any abdominal or pelvic tumor, except for the treatment of ovarian, fallopian tube, or primary peritoneal cancer

• Prior adjuvant chemotherapy for localized breast cancer allowed provided it was completed > 3 years ago and the patient remains free of recurrent or metastatic disease

• No prior elesclomol sodium

• No prior second-line cytotoxic chemotherapy

• No prior cancer treatment that would contraindicate study therapy

Trial Contact Information

Trial Lead Organizations/Sponsors

Gynecologic Oncology Group

Bradley J. Monk

Study Chair

U.S.A.
Texas
	Houston
	M. D. Anderson Cancer Center at University of Texas
		Lois M. Ramondetta
			Email: lramonde@mdanderson.org

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00888615
Information obtained from ClinicalTrials.gov on November 20, 2012

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