Clinical Trial Details
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NCT02535312 : Methoxyamine, Cisplatin, and Pemetrexed Disodium in Treating Patients With Advanced Solid Tumors or Mesothelioma That Cannot Be Removed by Surgery or Mesothelioma That Is Refractory to Cisplatin and Pemetrexed
PhasePhase 1/Phase 2
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

- Arm A dose escalation: patients with histologically or cytologically proven advanced
solid tumors for which standard treatments are not available; =< 2 prior cytotoxic
chemotherapy regimen; prior cumulative dose of cisplatin < 300 mg/m^2

- Arm A dose level 4 (75 mg/m^2 cisplatin): patients with histologically proven
chemotherapy-naïve advanced unresectable solid tumors for which pemetrexed combined
with cisplatin is an indicated regimen (malignant mesothelioma, non-small cell lung
cancer, ovarian cancer and thymoma)

- Arm A 14-patients expansion cohort: patients with histologically or cytologically
proven chemotherapy naïve unresectable malignant pleural or peritoneal mesothelioma

- Arm B (first stage of phase II of TRC102 and pemetrexed): patients with malignant
pleural or peritoneal mesothelioma who had progressed while being treated with or had
recurred within 3 months of being treated with pemetrexed and cisplatin or
carboplatin frontline

- Prior pemetrexed is allowed except Arm A dose level 4 (cisplatin 75 mg/m^2)

- Eastern Cooperative Oncology Group (ECOG) performance status 0 -1 (Karnofsky >= 70%)

- Life expectancy of greater than 3 months

- Absolute neutrophil count >= 1,500/uL

- Platelets >= 100,000/uL

- Hemoglobin >= 10.0 g/dl

- Prothrombin time or international normalized ratio (INR) =< 1.5 x upper limit of
normal (ULN)

- Total bilirubin < 1.5 x ULN

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate [SGPT]) =< 2.5 x
institutional ULN or =< 5 x ULN if metastatic disease involves liver

- Serum creatinine =< 1.5 x ULN or a calculated creatinine clearance >= 60 ml/min/1.73
m^2 (Cockcroft-Gault method) for patients receiving combination of cisplatin and
pemetrexed and >= 45 ml/min/1.73 m^2 for patients receiving pemetrexed; 24 hour urine
for creatinine clearance is acceptable if the calculated creatinine clearance is

- For patients enrolled in arm A dose level 4, arm A 14-patients expansion cohort, and
arm B (first stage of phase II of TRC102 and pemetrexed) measurable disease is
required according to the Response Evaluation Criteria in Solid Tumors (RECIST)
criteria for patients with solid tumors and modified RECIST criteria as described by
Byrne and Novak for patients with malignant pleural mesothelioma; pleural effusion
and ascites are not considered measurable disease

- Patients must be able to swallow whole capsules; nasogastric or gastrointestinal
(G)-tube administration is not allowed

- Women of child-bearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control; abstinence) prior to study entry, for
the duration of study participation, and 4 months after completion of the study
drugs; should a woman become pregnant or suspect she is pregnant while she or her
partner is participating in this study, she should inform her treating physician
immediately; men treated or enrolled on this protocol must also agree to use adequate
contraception prior to the study, for the duration of study participation, and 4
months after completion of TRC102, pemetrexed and cisplatin administration

- Non-childbearing potential is defined as (by other than medical reasons): >= 45
years of age and has not had menses for >= 2 years, amenorrheic for < 2 years
without hysterectomy and oophorectomy and a follicle-stimulating hormone value
in the postmenopausal range upon pretrial (screening) evaluation, or post
hysterectomy, oophorectomy or tubal ligation; documented hysterectomy or
oophorectomy must be confirmed with medical records of the actual procedure or
confirmed by ultrasound; tubal ligation must be confirmed with medical records
of the actual procedure otherwise the patient must be willing to use 2 adequate
barrier methods throughout the study, starting with the screening visit though 4
months after the last dose of study drugs

- Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for
nitrosoureas or mitomycin C) prior to entering the study or those who have not
recovered from adverse events due to agents administered more than 4 weeks earlier;
patients who have had targeted therapy will be required to wait 2 weeks due to short
half-life of the drugs; treatment with bisphosphonates is permitted

- Patients who are receiving any other investigational agents

- Patients with active brain metastases or carcinomatous meningitis are excluded from
this clinical trial; patients with treated brain metastases, whose brain metastatic
disease has remained stable for greater than or equal to 4 weeks without requiring
steroid and anti-seizure medications are eligible to participate

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to TRC102 or pemetrexed and cisplatin

- No studies have been performed to assess potential metabolic and transport
interactions of TRC102; as part of the enrollment/informed consent procedures, the
patient will be counseled on the risk of interactions with other agents, and what to
do if new medications need to be prescribed or if the patient is considering a new
over-the-counter medicine or herbal product; the case report form must capture the
concurrent use of all other drugs, over-the-counter medications, or alternative

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements

- Pregnant women are excluded from this study; breastfeeding should be discontinued if
the mother is treated with TRC102

- Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral
therapy are ineligible

- Patients with known disorders associated with hemolysis

- Patients with thromboembolic disease and on anticoagulation

- Patients with a prior cumulative cisplatin dose > 300 mg/m^2
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