A Phase 1 and 2 Clinical Trial of ALIMTA (Pemetrexed) in Combination with Carboplatin in Patients with Recurrent Ovarian or Primary Peritoneal Cancer(Sweden will participate in Phase 2 of this trial, only)

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 85

Inclusion Criteria

Patients are eligible to be included in the study only if they meet all of the following criteria:
[1] histologic diagnosis of ovarian or primary peritoneal cancer that is not amenable to curative therapy.
[2] patients must have platinum-sensitive recurrent ovarian cancer.
Platinum sensitive ovarian cancer is defined as disease that recurs at least 6 months after completion of prior platinum-based therapy. Best response to prior platinum-based therapy must have been CR, PR, SD, or not evaluable due to optimal debulking surgery.
[3] prior radiation therapy is allowed, and patients must have recovered from the acute toxic effects of the treatment prior to study entry, but must have been completed at least 2 weeks prior to study enrollment. Prior radiation therapy must not have involved more than 25% of the bone marrow.
[4] patients enrolling in the Phase 1 portion of the protocol may have either measurable or nonmeasurable disease as defined by Response Criteria in Solid Tumors (RECIST) guidelines. (Therasse et al. 2000; refer to Section 6.1.1.3)
[5] patients enrolling in the Phase 2 portion of the protocol must have:
- measurable disease as defined by the RECIST guidelines,
or
[6] performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) scale (Protocol Attachment JMHH.3).
[7] estimated life expectancy of at least 24 weeks.
[8] patient compliance and geographic proximity that allow adequate follow-up.
[9] adequate organ function including the following:
- adequate bone marrow reserve: absolute neutrophil count (ANC) =1.5 x 10e9/L, platelets =100 x 10e9/L, and hemoglobin =9 g/dL.
- hepatic: bilirubin =1.5 times the upper limit of normal (ULN), alkaline phosphatase (AP), aspartate transaminase (AST) and alanine transaminase (ALT) =3.0 times ULN (AP, AST, and ALT =5.0 times ULN is acceptable if due to liver metastases).
- renal: calculated creatinine clearance (CrCl) =45 mL/min based on the standard Cockcroft and Gault formula or on measured GFR using the appropriate radiolabeled method (51-CrEDTA or Tc99m-DTPA).
[10] signed informed consent from patient or legal representative is required.
[11] women at least 18 years of age.
[12] patients with reproductive potential must use a reliable contraceptive method if appropriate (for example, intrauterine device [IUD], birth control pills, or barrier device) during the study. Patients with reproductive potential must have a negative serum or urine pregnancy test within 7 days of study enrollment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients will be excluded from the study if they meet any of the following criteria:
[13] more than 2 lines of therapy for ovarian or primary peritoneal cancer.
This includes high-dose therapy, consolidation therapy, maintenance therapy, or noncytotoxic targeted agents. Noncytotoxic targeted agents include (but are not limited to) hormonal therapies, monoclonal antibodies, cytokines, small molecule inhibitors of signal transduction, or any other agents with anti-tumor activity.
[14] pregnant or breast feeding.
[15] serious concomitant systemic disorders (for example, active infection) that, in the opinion of the investigator, would compromise the safety of the patient and her ability to complete the study.
[16] have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
[17] inability to interrupt the use of aspirin and/or other nonsteroidal anti-inflammatory agents for 2 days before, the day of, and 2 days after the dose of pemetrexed (5 days prior for long-acting agents, such as piroxicam).
[18] peripheral neuropathy =NCI Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 (see CTCAE Investigator Guide, Version 3.0).
[19] inability or unwillingness to take folic acid and vitamin B12 supplementation, and corticosteroids.
[20] previous completion of or withdrawal from this study or any other study investigating pemetrexed.
[21] inability to comply with protocol or study procedures.
[22] have a clinically significant third-space fluid (for example, pleural effusion or ascites) that cannot be managed with drainage.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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