Carboplatin/Pralatrexate in Recurrent Platinum-Sensitive Ovarian, Fallopian or Primary Peritoneal Cancer

Browse trials for

• Fallopian Tube Neoplasms 720
• Peritoneal Neoplasms 361
• Hypersensitivity 1,916

Keywords

• carboplatin
• recurrent
• platinum sensitive
• pralatrexate

Fallopian Tube Neoplasms

720 studies on the registry are indexed under Fallopian Tube Neoplasms; 127 are open to participants now.

This study's enrollment of 50 is close to the median of 52 across 589 interventional studies indexed under Fallopian Tube Neoplasms.

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.

Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.

Study arms

• Experimental
  Carboplatin/Pralatrexate

  Drug: carboplatin · Drug: pralatrexate · Drug: Folic Acid · Drug: Vitamin B12 Injection

Interventions

• Drugcarboplatin

  Given intravenously on Day 1 of each 28-day cycle

• Drugpralatrexate

  Given intravenously on Day 1 and Day 15 of each 28-day cycle.

• DrugFolic Acid

  Given orally on a daily basis starting 7 days before the first dose of pralatrexate and continuing until 30 days after the last dose of pralatrexate.

• DrugVitamin B12 Injection

  Given vitamin B12 injection no more than 10 weeks prior to the first dose of pralatrexate and every 8-10 weeks after the first dose of pralatrexate.

Primary outcomes

1. Maximum Tolerated Dose (MTD)

   The maximum tolerated dose of Pralatrexate in combination with Carboplatin in this patient population. The unit is given in milligrams per square meter of body surface area. MTD was determined using a standard 3 + 3 dose escalation cohort, where 3 participants were enrolled on the starting dose of 30 mg/m2 and if no dose limiting toxicities (DLT) were experienced after a full cycle, 3 additional participants were enrolled at the next highest dose level. Each increase in dose level escalated the dose of Pralatrexate by 15 mg/m2. If during any dose level, 1 patient out of 3 develops a DLT, then 3 additional patients will be added to that dose level. If 2 out of the 3 patients placed on any dose level experience a DLT, the preceding dose is considered MTD. If 1/6 has a DLT, the next higher dose level will commence accrual (unless at level +5 and then accrual to the Phase I portion will stop). If ≥ 2 of 6 patients have a DLT, then the preceding dose will be considered MTD.

   Time frame: 1 year

2. Best Overall Response

   Summary of the best overall responses to treatment as assessed by RECIST (Response Evaluation Criteria In Solid Tumors). * Complete Response (CR): Disappearance of all target lesions * Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD * Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started * Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions

   Time frame: 1 Year

Secondary outcomes

1. Overall Survival

   The number of participants still alive at the given time points. The duration of time is measured from the start of treatment until death due to any cause, participants are censored at the date of the last evaluation. The number participants surviving at 6, 12, 18, and 24 months is shown.

   Time frame: 6, 12, 18, and 24 months

2. Progression Free Survival

   The number of participants alive and without disease progression at the given time-points. Time is measured from the start of treatment. Progression is defined as having at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

   Time frame: 3 months, 6 months

3. Treatment Related Adverse Events

   Summary of the treatment related adverse events experienced by participants as assessed by Common Terminology Criteria for Adverse Events (CTCAE 4). Adverse events were assessed from the start of treatment until 30 days after the last dose of study drug.

   Time frame: 1 Year

4. Maximum Concentration of Drug in Plasma (Cmax)

   The maximum concentration of Pralatrexate at day 1 and 15 among phase 1 participants dosed at 105 milligrams per square meter of body surface area (mg/m2). The concentration is given in micrograms per milliliter.

   Time frame: Day 1 and Day 15

5. Area Under the Plasma Drug Concentration-Time Curve (AUC)

   Area under the plasma drug concentration-time curve (AUC) for phase 1 participants that were dosed at 105 mg/m2. AUC represents the actual body exposure to drug after administration of a dose of the drug and is expressed in micrograms \* hour per milliliter (ug\*h/mL).

   Time frame: Day 1 and Day 15

Baseline characteristics